Orthopedic Device Classification Codes

HRS Class 2

Plate, Fixation, Bone

Clearances 1194

Regulation 21 CFR 888.3030

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HWC Class 2

Screw, Fixation, Bone

Clearances 996

Regulation 21 CFR 888.3040

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JWH Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Clearances 861

Regulation 21 CFR 888.3560

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NKB Class 2

Thoracolumbosacral Pedicle Screw System

Clearances 809

Regulation 21 CFR 888.3070

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MAX Class 2

Intervertebral Fusion Device With Bone Graft, Lumbar

Clearances 785

Regulation 21 CFR 888.3080

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HRX Class 2

Arthroscope

Clearances 670

Regulation 21 CFR 888.1100

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KWQ Class 2

Appliance, Fixation, Spinal Intervertebral Body

Clearances 626

Regulation 21 CFR 888.3060

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JDI Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Clearances 558

Regulation 21 CFR 888.3350

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MBI Class 2

Fastener, Fixation, Nondegradable, Soft Tissue

Clearances 558

Regulation 21 CFR 888.3040

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LPH Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Clearances 527

Regulation 21 CFR 888.3358

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LZO Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Clearances 509

Regulation 21 CFR 888.3353

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HSB Class 2

Rod, Fixation, Intramedullary And Accessories

Clearances 490

Regulation 21 CFR 888.3020

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MQV Class 2

Filler, Bone Void, Calcium Compound

Clearances 455

Regulation 21 CFR 888.3045

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KWP Class 2

Appliance, Fixation, Spinal Interlaminal

Clearances 408

Regulation 21 CFR 888.3050

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KTT Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Clearances 378

Regulation 21 CFR 888.3030

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ODP Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Clearances 304

Regulation 21 CFR 888.3080

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MNH Class 2

Orthosis, Spondylolisthesis Spinal Fixation

Clearances 287

Regulation 21 CFR 888.3070

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MNI Class 2

Orthosis, Spinal Pedicle Fixation

Clearances 285

Regulation 21 CFR 888.3070

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MQP Class 2

Spinal Vertebral Body Replacement Device

Clearances 266

Regulation 21 CFR 888.3060

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JDR Class 2

Staple, Fixation, Bone

Clearances 215

Regulation 21 CFR 888.3030

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MAI Class 2

Fastener, Fixation, Biodegradable, Soft Tissue

Clearances 212

Regulation 21 CFR 888.3030

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HTY Class 2

Pin, Fixation, Smooth

Clearances 189

Regulation 21 CFR 888.3040

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PHX Class 2

Shoulder Prosthesis, Reverse Configuration

Clearances 189

Regulation 21 CFR 888.3660

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OVD Class 2

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Clearances 179

Regulation 21 CFR 888.3080

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KWS Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Clearances 176

Regulation 21 CFR 888.3660

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MEH Class 2

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Clearances 158

Regulation 21 CFR 888.3353

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OVE Class 2

Intervertebral Fusion Device With Integrated Fixation, Cervical

Clearances 144

Regulation 21 CFR 888.3080

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MBH Class 2

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Clearances 129

Regulation 21 CFR 888.3565

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JDQ Class 2

Cerclage, Fixation

Clearances 123

Regulation 21 CFR 888.3010

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OUR Class 2

Sacroiliac Joint Fixation

Clearances 121

Regulation 21 CFR 888.3040

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HSX Class 2

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Clearances 114

Regulation 21 CFR 888.3520

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KWA Class 3

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Clearances 114

Regulation 21 CFR 888.3330

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KWL Class 2

Prosthesis, Hip, Hemi-, Femoral, Metal

Clearances 107

Regulation 21 CFR 888.3360

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NKG Class 2

Posterior Cervical Screw System

Clearances 102

Regulation 21 CFR 888.3075

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KWY Class 2

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Clearances 97

Regulation 21 CFR 888.3390

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NDN Class 2

Cement, Bone, Vertebroplasty

Clearances 95

Regulation 21 CFR 888.3027

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JDW Class 2

Pin, Fixation, Threaded

Clearances 91

Regulation 21 CFR 888.3040

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HRY Class 2

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Clearances 89

Regulation 21 CFR 888.3530

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JEC Class 2

Component, Traction, Invasive

Clearances 84

Regulation 21 CFR 888.3040

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HTN Class 2

Washer, Bolt Nut

Clearances 83

Regulation 21 CFR 888.3030

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LWJ Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Clearances 81

Regulation 21 CFR 888.3360

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KRO Class 2

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Clearances 79

Regulation 21 CFR 888.3510

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HSD Class 2

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Clearances 70

Regulation 21 CFR 888.3690

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KWT Class 2

Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Clearances 69

Regulation 21 CFR 888.3650

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LOD Class 2

Bone Cement

Clearances 67

Regulation 21 CFR 888.3027

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HSN Class 2

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Clearances 63

Regulation 21 CFR 888.3110

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JDG Class 2

Prosthesis, Hip, Femoral Component, Cemented, Metal

Clearances 59

Regulation 21 CFR 888.3360

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LXH Class 1

Orthopedic Manual Surgical Instrument

Clearances 57

Regulation 21 CFR 888.4540

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LXT Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Clearances 57

Regulation 21 CFR 888.3030

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JDS Class 2

Nail, Fixation, Bone

Clearances 52

Regulation 21 CFR 888.3030

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KWD Class 2

Prosthesis, Toe, Hemi-, Phalangeal

Clearances 46

Regulation 21 CFR 888.3730

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JDL Class 3

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Clearances 45

Regulation 21 CFR 888.3320

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HST Class 1

Apparatus, Traction, Non-Powered

Clearances 38

Regulation 21 CFR 888.5850

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KTW Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Clearances 38

Regulation 21 CFR 888.3030

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LBB Class 2

Dynamometer, Ac-Powered

Clearances 36

Regulation 21 CFR 888.1240

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MBF Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Clearances 36

Regulation 21 CFR 888.3670

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KWZ Class 2

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Clearances 34

Regulation 21 CFR 888.3310

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PEK Class 2

Spinous Process Plate

Clearances 34

Regulation 21 CFR 888.3050

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KQX Class 1

Goniometer, Ac-Powered

Clearances 33

Regulation 21 CFR 888.1500

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KWI Class 2

Prosthesis, Elbow, Hemi-, Radial, Polymer

Clearances 33

Regulation 21 CFR 888.3170

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LGF Class 1

Component, Cast

Clearances 31

Regulation 21 CFR 888.5940

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OWI Class 2

Bone Fixation Cerclage, Sublaminar

Clearances 31

Regulation 21 CFR 888.3010

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MBP Class 2

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Clearances 30

Regulation 21 CFR 888.3045

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NQW Class 2

Orthosis, Spine, Plate, Laminoplasty, Metal

Clearances 29

Regulation 21 CFR 888.3050

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JDC Class 2

Prosthesis, Elbow, Constrained, Cemented

Clearances 28

Regulation 21 CFR 888.3150

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JDB Class 2

Prosthesis, Elbow, Semi-Constrained, Cemented

Clearances 27

Regulation 21 CFR 888.3160

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KRR Class 2

Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Clearances 26

Regulation 21 CFR 888.3540

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KYI Class 2

Prosthesis, Wrist, Carpal Trapezium

Clearances 26

Regulation 21 CFR 888.3770

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PBF Class 2

Orthopaedic Surgical Planning And Instrument Guides

Clearances 26

Regulation 21 CFR 888.3030

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QHE Class 2

Shoulder Arthroplasty Implantation System

Clearances 26

Regulation 21 CFR 888.3660

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JDX Class 2

Instrument, Surgical, Sonic And Accessory/Attachment

Clearances 23

Regulation 21 CFR 888.4580

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KXA Class 2

Prosthesis, Hip, Femoral, Resurfacing

Clearances 23

Regulation 21 CFR 888.3400

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JDO Class 2

Device, Fixation, Proximal Femoral, Implant

Clearances 22

Regulation 21 CFR 888.3030

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KWH Class 2

Prosthesis, Toe, Constrained, Polymer

Clearances 21

Regulation 21 CFR 888.3720

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NQP Class 2

Posterior Metal/Polymer Spinal System, Fusion

Clearances 21

Regulation 21 CFR 888.3070

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PKC Class 2

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Clearances 19

Regulation 21 CFR 888.3660

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PML Class 2

Bone Cement, Posterior Screw Augmentation

Clearances 19

Regulation 21 CFR 888.3027

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OSH Class 2

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Clearances 18

Regulation 21 CFR 888.3070

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PLR Class 2

Spinal Vertebral Body Replacement Device - Cervical

Clearances 18

Regulation 21 CFR 888.3060

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MBB Class 2

Bone Cement, Antibiotic

Clearances 17

Regulation 21 CFR 888.3027

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JWJ Class 2

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Clearances 16

Regulation 21 CFR 888.3800

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OQG Class 2

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Clearances 16

Regulation 21 CFR 888.3358

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PLF Class 2

Bone Wedge

Clearances 16

Regulation 21 CFR 888.3030

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HXB Class 1

Probe

Clearances 15

Regulation 21 CFR 888.4540

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KXE Class 2

Prosthesis, Wrist, Hemi-, Ulnar

Clearances 15

Regulation 21 CFR 888.3810

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HTO Class 1

Reamer

Clearances 14

Regulation 21 CFR 888.4540

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MBV Class 2

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Clearances 14

Regulation 21 CFR 888.3560

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JDZ Class 1

Mixer, Cement, For Clinical Use

Clearances 13

Regulation 21 CFR 888.4210

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KQW Class 1

Goniometer, Nonpowered

Clearances 13

Regulation 21 CFR 888.1520

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KYJ Class 2

Prosthesis, Finger, Constrained, Polymer

Clearances 13

Regulation 21 CFR 888.3230

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MBL Class 2

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Clearances 13

Regulation 21 CFR 888.3358

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HRW Class 1

Dynamometer, Nonpowered

Clearances 12

Regulation 21 CFR 888.1250

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OIY Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Clearances 12

Regulation 21 CFR 888.3560

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HTW Class 1

Bit, Drill

Clearances 11

Regulation 21 CFR 888.4540

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HXA Class 2

Prosthesis, Tendon, Passive

Clearances 11

Regulation 21 CFR 888.3025

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KIH Class 1

Dispenser, Cement

Clearances 11

Regulation 21 CFR 888.4200

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KQZ Class 1

Component, Traction, Non-Invasive

Clearances 11

Regulation 21 CFR 888.5890

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NPJ Class 2

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Clearances 11

Regulation 21 CFR 888.3560

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HWT Class 1

Template

Clearances 10

Regulation 21 CFR 888.4800

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HTS Class 1

Knife, Orthopedic

Clearances 9

Regulation 21 CFR 888.4540

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HWQ Class 1

Passer

Clearances 9

Regulation 21 CFR 888.4540

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LGH Class 1

Instrument, Cast Removal, Ac-Powered

Clearances 9

Regulation 21 CFR 888.5960

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LYT Class 2

Fixation Accessory

Clearances 9

Regulation 21 CFR 888.3030

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PGM Class 2

Growing Rod System

Clearances 9

Regulation 21 CFR 888.3070

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QLQ Class 2

Manual Instruments Designed For Use With Total Disc Replacement Devices

Clearances 9

Regulation 21 CFR 888.4515

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HRR Class 1

Scissors, Orthopedic, Surgical

Clearances 8

Regulation 21 CFR 888.4540

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JDY Class 1

Evacuator, Vapor, Cement Monomer

Clearances 8

Regulation 21 CFR 888.4220

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LRN Class 2

Wire, Surgical

Clearances 8

Regulation 21 CFR 888.3030

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LZY Class 2

Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Clearances 8

Regulation 21 CFR 888.3360

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PQC Class 2

Pedicle Screw Placement Guide

Clearances 8

Regulation 21 CFR 888.3070

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HXY Class 1

Brace, Drill

Clearances 7

Regulation 21 CFR 888.4540

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KTZ Class 1

Caliper

Clearances 7

Regulation 21 CFR 888.4150

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LZV Class 2

System, Cement Removal Extraction

Clearances 7

Regulation 21 CFR 888.4580

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OYK Class 2

Ankle Arthroplasty Implantation System

Clearances 7

Regulation 21 CFR 888.3110

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HXC Class 1

Wrench

Clearances 6

Regulation 21 CFR 888.4540

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HXJ Class 1

Staple Driver

Clearances 6

Regulation 21 CFR 888.4540

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JDN Class 2

Implant, Fixation Device, Spinal

Clearances 6

Regulation 21 CFR 888.3060

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KWM Class 2

Prosthesis, Wrist, Semi-Constrained

Clearances 6

Regulation 21 CFR 888.3800

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OBT Class 2

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Clearances 6

Regulation 21 CFR 888.3030

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QAD Class 2

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Clearances 6

Regulation 21 CFR 888.3023

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HSH Class 2

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Clearances 5

Regulation 21 CFR 888.3590

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HTP Class 1

File

Clearances 5

Regulation 21 CFR 888.4540

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HTX Class 1

Rongeur

Clearances 5

Regulation 21 CFR 888.4540

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HWB Class 1

Extractor

Clearances 5

Regulation 21 CFR 888.4540

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HXK Class 1

Holder, Needle; Orthopedic

Clearances 5

Regulation 21 CFR 888.4540

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HXP Class 1

Instrument, Bending Or Contouring

Clearances 5

Regulation 21 CFR 888.4540

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OQI Class 2

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Clearances 5

Regulation 21 CFR 888.3353

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PGN Class 2

Growing Rod System- Magnetic Actuation

Clearances 5

Regulation 21 CFR 888.3070

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HTJ Class 1

Gauge, Depth

Clearances 4

Regulation 21 CFR 888.4300

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HTT Class 1

Burr, Orthopedic

Clearances 4

Regulation 21 CFR 888.4540

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HWA Class 1

Impactor

Clearances 4

Regulation 21 CFR 888.4540

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HWJ Class 1

Awl

Clearances 4

Regulation 21 CFR 888.4540

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HWN Class 1

Instrument, Compression

Clearances 4

Regulation 21 CFR 888.4540

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HWR Class 1

Driver, Prosthesis

Clearances 4

Regulation 21 CFR 888.4540

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HXX Class 1

Screwdriver

Clearances 4

Regulation 21 CFR 888.4540

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KWN Class 2

Prosthesis, Wrist, Carpal Lunate

Clearances 4

Regulation 21 CFR 888.3750

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LYS Class 1

Bone Mill

Clearances 4

Regulation 21 CFR 888.4540

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MAY Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Clearances 4

Regulation 21 CFR 888.3353

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MNU Class 2

Staple, Absorbable

Clearances 4

Regulation 21 CFR 888.3030

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NJD Class 2

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Clearances 4

Regulation 21 CFR 888.3535

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HSS Class 1

Halter, Head, Traction

Clearances 3

Regulation 21 CFR 888.5890

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HTH Class 1

Protractor

Clearances 3

Regulation 21 CFR 888.4600

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HXO Class 1

Pusher, Socket

Clearances 3

Regulation 21 CFR 888.4540

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HXW Class 1

Bender

Clearances 3

Regulation 21 CFR 888.4540

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JWI Class 2

Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

Clearances 3

Regulation 21 CFR 888.3800

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KMC Class 2

Prosthesis, Hip, Semi-Constrained, Composite/Metal

Clearances 3

Regulation 21 CFR 888.3340

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KYK Class 2

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

Clearances 3

Regulation 21 CFR 888.3500

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LGG Class 1

Instrument, Cast Application/Removal, Manual

Clearances 3

Regulation 21 CFR 888.5980

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LYQ Class 1

Accessories, Fixation, Spinal Intervertebral Body

Clearances 3

Regulation 21 CFR 888.4540

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NDF Class 2

Plate, Fixation, Bone, Non-Spinal, Metallic

Clearances 3

Regulation 21 CFR 888.3030

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OQB Class 2

Intervertebral Body Graft Containment Device

Clearances 3

Regulation 21 CFR 888.3085

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OSN Class 2

Software For Diagnosis/Treatment

Clearances 3

Regulation 21 CFR 888.3030

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QPP Class 2

Implantable Post-Surgical Kinematic Measurement Knee Device

Clearances 3

Regulation 21 CFR 888.3600

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HTG Class 2

Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

Clearances 2

Regulation 21 CFR 888.3580

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HWX Class 1

Tap, Bone

Clearances 2

Regulation 21 CFR 888.4540

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HXI Class 1

Passer, Wire, Orthopedic

Clearances 2

Regulation 21 CFR 888.4540

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HXN Class 1

Applier, Cerclage

Clearances 2

Regulation 21 CFR 888.4540

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HXS Class 1

Twister, Wire

Clearances 2

Regulation 21 CFR 888.4540

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JDP Class 2

Condylar Plate Fixation Implant

Clearances 2

Regulation 21 CFR 888.3030

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LGE Class 2

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

Clearances 2

Regulation 21 CFR 888.3530

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MJW Class 2

Prosthesis, Subtalar, Plug, Polymer

Clearances 2

Regulation 21 CFR 888.3040

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NBH Class 1

Accessories, Arthroscopic

Clearances 2

Regulation 21 CFR 888.1100

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NDK Class 2

System, External Fixator (With Metallic Invasive Components)

Clearances 2

Regulation 21 CFR 888.3040

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NDL Class 2

Pin, Fixation, Smooth, Metallic

Clearances 2

Regulation 21 CFR 888.3040

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NGR Class 2

Tester, Stiffness, Cartilage, Arthroscopic

Clearances 2

Regulation 21 CFR 888.1100

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OJB Class 2

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Clearances 2

Regulation 21 CFR 888.3060

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OOG Class 2

Knee Arthroplasty Implantation System

Clearances 2

Regulation 21 CFR 888.3560

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OVZ Class 2

Pin, Fixation, Resorbable, Hard Tissue

Clearances 2

Regulation 21 CFR 888.3040

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OZI Class 2

Internal Hinged Elbow Fixator

Clearances 2

Regulation 21 CFR 888.3030

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PBI Class 2

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Clearances 2

Regulation 21 CFR 888.3310

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PHM Class 2

Intervertebral Fusion Device With Bone Graft, Thoracic

Clearances 2

Regulation 21 CFR 888.3080

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QBO Class 2

Instruments Designed For Press-Fit Osteochondral Implants

Clearances 2

Regulation 21 CFR 888.4505

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QGQ Class 2

Bone Indentation Device

Clearances 2

Regulation 21 CFR 888.1600

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QNI Class 2

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Clearances 2

Regulation 21 CFR 888.3044

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QSD Class 2

Posterior Cervical Screw Placement Guide

Clearances 2

Regulation 21 CFR 888.3075

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QVI Class 2

Screw Sleeve Bone Fixation Device, Spine

Clearances 2

Regulation 21 CFR 888.3043

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QWL Class 2

Intraoperative Surgical Angle Measurement Tool

Clearances 2

Regulation 21 CFR 888.4560

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QZZ Class 2

Limb And Joint Salvage Device With Coating For Bacteria Reduction

Clearances 2

Regulation 21 CFR 888.3900

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SAI Class 2

Ankle Fusion Cage

Clearances 2

Regulation 21 CFR 888.3020

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HSP Class 1

Splint, Traction

Clearances 1

Regulation 21 CFR 888.5890

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HSQ Class 1

Belt, Pelvic, Traction

Clearances 1

Regulation 21 CFR 888.5890

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HSR Class 1

Unit, Traction, Hip, Non-Powered, Non-Penetrating

Clearances 1

Regulation 21 CFR 888.5890

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HWI Class 1

Corkscrew

Clearances 1

Regulation 21 CFR 888.4540

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HWK Class 1

Trephine

Clearances 1

Regulation 21 CFR 888.4540

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HWP Class 1

Punch, Femoral Neck

Clearances 1

Regulation 21 CFR 888.4540

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HXG Class 1

Tamp

Clearances 1

Regulation 21 CFR 888.4540

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HXZ Class 1

Cutter, Wire

Clearances 1

Regulation 21 CFR 888.4540

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KIL Class 1

Positioner, Socket

Clearances 1

Regulation 21 CFR 888.4540

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KWK Class 2

Appliance, Nail/Blade/Plate Combination, Single Component

Clearances 1

Regulation 21 CFR 888.3030

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KWO Class 2

Prosthesis, Wrist, Carpal Scaphoid

Clearances 1

Regulation 21 CFR 888.3760

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LYP Class 2

Accessories, Fixation, Spinal Interlaminal

Clearances 1

Regulation 21 CFR 888.3050

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LZE Class 1

Isometer

Clearances 1

Regulation 21 CFR 888.1520

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MDI Class 2

Prosthesis, Rib Replacement

Clearances 1

Regulation 21 CFR 888.3070

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NDD Class 2

Cerclage, Fixation, Metallic

Clearances 1

Regulation 21 CFR 888.3010

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NDG Class 2

Washer, Bolt, Nut, Non-Spinal, Metallic

Clearances 1

Regulation 21 CFR 888.3030

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NDM Class 2

Pin, Fixation, Threaded, Metallic

Clearances 1

Regulation 21 CFR 888.3040

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NKI Class 2

Goniometer With Electrodes

Clearances 1

Regulation 21 CFR 888.1500

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NOV Class 2

Anchor, Suture, Bone Fixation, Metallic

Clearances 1

Regulation 21 CFR 888.3030

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OAR Class 1

Injector, Vertebroplasty (Does Not Contain Cement)

Clearances 1

Regulation 21 CFR 888.4200

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OBL Class 2

Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

Clearances 1

Regulation 21 CFR 888.3027

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OCJ Class 1

Spinal Channeling Instrument, Vertebroplasty

Clearances 1

Regulation 21 CFR 888.4540

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OIS Class 2

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Clearances 1

Regulation 21 CFR 888.3045

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OOL Class 2

Electronic Depth Gauge

Clearances 1

Regulation 21 CFR 888.3030

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PAO Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

Clearances 1

Regulation 21 CFR 888.3660

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PHQ Class 2

Anterior Staple As Supplemental Fixation For Fusion

Clearances 1

Regulation 21 CFR 888.3060

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QHG Class 2

Defect Measurement Tool

Clearances 1

Regulation 21 CFR 888.4510

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QHQ Class 2

Total Shoulder Arthroplasty System

Clearances 1

Regulation 21 CFR 888.3660

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QLR Class 2

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Clearances 1

Regulation 21 CFR 888.4520

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QRR Class 2

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Clearances 1

Regulation 21 CFR 888.3046

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QSR Class 2

Sacroiliac Screw Placement Guide

Clearances 1

Regulation 21 CFR 888.3040

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QVL Class 2

Absorbable Gel For Intraoperative Use In Spine Surgery

Clearances 1

Regulation 21 CFR 888.3047

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SCY Class 2

Sacroiliac Joint Guidewire Placement Device

Clearances 1

Regulation 21 CFR 888.3040

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SGL Class 2

Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant

Clearances 1

Regulation 21 CFR 888.4520

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SIN Class 2

Automated Intraoperative Spinal Rod Bending System

Clearances 1

Regulation 21 CFR 888.3070

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HRT Class 1

Stripper, Surgical

Clearances 0

Regulation 21 CFR 888.4540

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HRZ Class 3

Prosthesis, Knee, Hinged (Metal-Metal)

Clearances 0

Regulation 21 CFR 888.3480

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HSA Class 3

Prosthesis, Knee, Hemi-, Femoral

Clearances 0

Regulation 21 CFR 888.3570

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HTQ Class 1

Broach

Clearances 0

Regulation 21 CFR 888.4540

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HWD Class 1

Starter, Bone Screw

Clearances 0

Regulation 21 CFR 888.4540

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HWL Class 1

Set, Hollow Mill

Clearances 0

Regulation 21 CFR 888.4540

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HWO Class 1

Skid, Bone

Clearances 0

Regulation 21 CFR 888.4540

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HWW Class 1

Countersink

Clearances 0

Regulation 21 CFR 888.4540

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HXE Class 1

Fork

Clearances 0

Regulation 21 CFR 888.4540

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HXQ Class 1

Crimper, Pin

Clearances 0

Regulation 21 CFR 888.4540

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JDD Class 2

Prosthesis, Upper Femoral

Clearances 0

Regulation 21 CFR 888.3360

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JDH Class 3

Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

Clearances 0

Regulation 21 CFR 888.3380

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JDT Class 1

Cap, Bone

Clearances 0

Regulation 21 CFR 888.3000

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KIG Class 2

Prosthesis, Wrist, Constrained, Polymer

Clearances 0

Regulation 21 CFR 888.3780

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KII Class 1

Tube, Cement Ventilation

Clearances 0

Regulation 21 CFR 888.4230

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KMB Class 2

Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented

Clearances 0

Regulation 21 CFR 888.3490

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KMD Class 2

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite

Clearances 0

Regulation 21 CFR 888.3100

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KRN Class 3

Metal Cemented Constrained Femorotibial Knee Prosthesis

Clearances 0

Regulation 21 CFR 888.3480

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KRP Class 3

Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

Clearances 0

Regulation 21 CFR 888.3550

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KRQ Class 2

Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer

Clearances 0

Regulation 21 CFR 888.3550

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KRS Class 3

Prosthesis, Knee, Hemi-, Femoral (Uncemented)

Clearances 0

Regulation 21 CFR 888.3570

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KTX Class 2

Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented

Clearances 0

Regulation 21 CFR 888.3490

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KWB Class 3

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

Clearances 0

Regulation 21 CFR 888.3370

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KWE Class 3

Prosthesis, Finger, Constrained, Metal, Uncemented

Clearances 0

Regulation 21 CFR 888.3200

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KWF Class 2

Prosthesis, Finger, Polymer

Clearances 0

Regulation 21 CFR 888.3230

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KWG Class 3

Prosthesis, Finger, Constrained, Metal/Polymer

Clearances 0

Regulation 21 CFR 888.3220

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KWJ Class 3

Prosthesis, Elbow, Hemi-, Humeral, Metal

Clearances 0

Regulation 21 CFR 888.3180

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KWR Class 3

Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

Clearances 0

Regulation 21 CFR 888.3640

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KXB Class 3

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Clearances 0

Regulation 21 CFR 888.3410

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KXC Class 3

Prosthesis, Ankle, Cemented, Non-Constrained

Clearances 0

Regulation 21 CFR 888.3120

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KXD Class 3

Prosthesis, Hip, Constrained, Metal

Clearances 0

Regulation 21 CFR 888.3300

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KYM Class 3

Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

Clearances 0

Regulation 21 CFR 888.3680

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KYN Class 3

Prosthesis, Wrist, Constrained, Metal

Clearances 0

Regulation 21 CFR 888.3790

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LBC Class 3

Prosthesis, Finger, Constrained, Metal, Cemented

Clearances 0

Regulation 21 CFR 888.3210

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LOF Class 2

Stimulator, Bone Growth, Non-Invasive

Clearances 0

Regulation 21 CFR 890.5870

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LPQ Class 2

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

Clearances 0

Regulation 21 CFR 890.5870

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LTO Class 3

Spacer, Cement

Clearances 0

Regulation 21 CFR 888.3320

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MRY Class 2

Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component

Clearances 0

Regulation 21 CFR 888.3040

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NDE Class 2

Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible

Clearances 0

Regulation 21 CFR 888.3020

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NDH Class 2

Nail, Fixation, Bone, Metallic

Clearances 0

Regulation 21 CFR 888.3030

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NDI Class 2

Staple, Fixation, Bone, Metallic

Clearances 0

Regulation 21 CFR 888.3030

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NDJ Class 2

Screw, Fixation, Bone, Non-Spinal, Metallic

Clearances 0

Regulation 21 CFR 888.3040

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NJA Class 2

Accessory, System, External Fixator, Containing Antimicrobial Agent

Clearances 0

Regulation 21 CFR 888.3040

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NUD Class 2

Vertebroplasty Compound, Calcium Based

Clearances 0

Regulation 21 CFR 888.3027

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NVC Class 3

Bone, Heterograft

Clearances 0

Regulation 21 CFR 888.3015

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NWN Class 2

Laparoscopic Bone Anchor Urethropexy Instrument Kit

Clearances 0

Regulation 21 CFR 888.3040

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OBM Class 2

Cement, Bone, Vertebroplasty, Pre-Formed, Modular

Clearances 0

Regulation 21 CFR 888.3027

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OCG Class 3

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

Clearances 0

Regulation 21 CFR 888.3410

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OJM Class 2

Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh

Clearances 0

Regulation 21 CFR 888.3060

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OQH Class 2

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Clearances 0

Regulation 21 CFR 888.3350

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PLW Class 2

Acetabular Cup Orientation System

Clearances 0

Regulation 21 CFR 888.3350

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PPQ Class 2

Transtibial Anterior Cruciate Ligament Kit

Clearances 0

Regulation 21 CFR 888.3040

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PPR Class 2

Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures

Clearances 0

Regulation 21 CFR 888.1100

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QAC Class 2

Screw Sleeve Bone Fixation Device

Clearances 0

Regulation 21 CFR 888.3043

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QFP Class 2

Intraoperative Orthopedic Strain Sensor

Clearances 0

Regulation 21 CFR 888.3090

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QJD Class 2

Absorbable Metallic Bone Fixation Fastener

Clearances 0

Regulation 21 CFR 888.3041

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QKW Class 2

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

Clearances 0

Regulation 21 CFR 888.3695

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QPQ Class 2

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Clearances 0

Regulation 21 CFR 888.3630

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QVV Class 2

Medial Knee Implanted Shock Absorber

Clearances 0

Regulation 21 CFR 888.3610

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QZO Class 2

Wearable Vibration Device For Orthopedic Use

Clearances 0

Regulation 21 CFR 888.5895

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QZY Class 2

Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

Clearances 0

Regulation 21 CFR 888.3071

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SIQ Class 2

Intra-Articular Orthopedic Stereotaxic Navigation Instrument

Clearances 0

Regulation 21 CFR 888.4561

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SIT Class 2

Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System

Clearances 0

Regulation 21 CFR 888.1150

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SJA Class 2

Injectable For Thermal Treatment Of Musculoskeletal Pain

Clearances 0

Regulation 21 CFR 888.3048

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