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Plate, Fixation, Bone

FDA product code HRS · 1194 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-16 – 2026-09-23

HRS 2022-10-03

Arthrex 2.4 mm Volar Distal Radius Plate System

Applicant Arthrex, Inc.

K number K222267

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HRS 2022-10-03

Varixis Elbow System

Applicant Auxein Medical Private Limited

K number K213014

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HRS 2022-09-30

Arthrex 3.5 mm Locking Compression Plates

Applicant Arthrex, Inc.

K number K222244

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HRS 2022-09-27

Medline UNITE® Medial Malleolus Peg Plate System

Applicant Medline Industries, LP

K number K221360

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HRS 2022-09-20

DePuy Synthes 3.5mm Intrapelvic Acetabular System

Applicant DePuy Synthes

K number K221809

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HRS 2022-09-02

Bonebridge Osteosynthesis Plating System

Applicant Bonebridge AG

K number K213864

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HRS 2022-08-31

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

Applicant I.T.S. GmbH

K number K210935

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HRS 2022-08-24

ARIX Small Fragment System

Applicant Jeil Medical Corporation

K number K221920

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HRS 2022-08-19

Baby Gorilla®/Gorilla® Plating System

Applicant Paragon 28, Inc.

K number K222194

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HRS 2022-07-08

Stryker VariAx 2 MIS Calcaneus

Applicant Stryker GmbH

K number K221346

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HRS 2022-07-01

Footmotion Plating System

Applicant Newclip Technics

K number K221395

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HRS 2022-06-29

Arthrex Mini Fragment System

Applicant Arthrex, Inc.

K number K220937

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HRS 2022-06-17

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K number K221465

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HRS 2022-06-10

Omni Foot and Ankle Plating System

Applicant Exremity Medical, LLC

K number K221362

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HRS 2022-05-27

CoLink PCR Plating System

Applicant In2bones USA, LLC

K number K213698

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HRS 2022-05-20

CalcShift™ Displacement Calcaneal Osteotomy System

Applicant Nextremity Solutions, Inc.

K number K212979

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HRS 2022-05-18

Osteotomy Truss System (OTS)

Applicant 4Web Medical, Inc.

K number K220463

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HRS 2022-05-17

SternaLock Sternal Closure System

Applicant Biomet Microfixation

K number K212782

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HRS 2022-05-02

Arthrx Fracture Plates

Applicant Arthrex, Inc.

K number K213837

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HRS 2022-05-02

ALPHALOK™ Plating System

Applicant Vilex, LLC

K number K212348

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HRS 2022-04-28

DVR® Crosslock Wrist Spanning Plate (131849181)

Applicant Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

K number K220244

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HRS 2022-04-22

RibFix Blu Thoracic Fixation System

Applicant Biomet Microfixation

K number K212608

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HRS 2022-04-05

DRPx Locking Distal Radius Plate System

Applicant Orthopaedic Implant Company

K number K212601

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HRS 2022-03-21

AFFINITY Proximal Tibia System

Applicant Techfit Digital Surgery, Inc.

K number K220199

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HRS 2022-03-14

2.4mm Distal Radius System

Applicant Auxein Medical Private Limited

K number K211324

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HRS 2022-03-11

Pectus Support Bar System

Applicant Biomet Microfixation

K number K213712

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HRS 2022-03-11

Apollo Ankle Fracture Plating System

Applicant Glw Medical, Inc.

K number K213005

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HRS 2022-03-11

Intai Anatomic Locking Plate and Screw System

Applicant Intai Technology Corporation

K number K201229

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HRS 2022-03-04

PolyLock Plating System

Applicant Fusion Orthopedics

K number K211843

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HRS 2022-03-02

Medline UNITE Calcaneal Fracture Plating System

Applicant Medline Industries, LP

K number K213567

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HRS 2022-02-23

Arsenal Ankle Plating System

Applicant Trilliant Surgical

K number K212378

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HRS 2022-02-18

Traufix osteosynthesis, osteotomy, and arthrodesis devices

Applicant Fixier S.A. DE C.V.

K number K201510

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HRS 2022-02-16

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K number K220136

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HRS 2022-02-11

FlexitSystem Knee osteotomy system

Applicant Neosteo

K number K212545

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HRS 2022-01-27

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

Applicant Wishbone Medical, Inc.

K number K213489

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HRS 2022-01-26

ANTHEM® Fracture System

Applicant Globus Medical, Inc.

K number K213591

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HRS 2022-01-26

SternaFuse Fixation System

Applicant Fusion Innovations, LLC

K number K202914

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HRS 2022-01-19

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

Applicant Stryker GmbH

K number K212581

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HRS 2022-01-13

Distal Humerus Plating System

Applicant Skeletal Dynamics, Inc.

K number K213895

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HRS 2022-01-07

Pectus Blu Support Bar System

Applicant Biomet Micofixation

K number K212841

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HRS 2022-01-07

GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

Applicant Gpc Medical Limited

K number K210198

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HRS 2021-12-16

Activmotion S DTO

Applicant Newclip Technics

K number K202803

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HRS 2021-12-13

CoLink NeoFuse Plating System

Applicant In2bones USA, LLC

K number K213069

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HRS 2021-11-24

Xpert Wrist

Applicant Newclip Technics

K number K213214

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HRS 2021-11-24

The Radian MIS Bunion System

Applicant Nvision Biomedical Technologies, Inc.

K number K211650

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HRS 2021-11-18

Stratum® Ankle Fusion Plating System

Applicant Nextremity Solutions, Inc.

K number K212640

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HRS 2021-11-18

CoLink Vallux Plating System

Applicant In2bones USA, LLC

K number K212487

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HRS 2021-10-18

LOQTEQ Proximal Humerus Plate 3.5 System

Applicant Aap Implantate AG

K number K211582

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HRS 2021-10-05

SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

Applicant Bonebridge AG

K number K203002

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HRS 2021-10-01

Anthem Fracture System

Applicant Globus Medical, Inc.

K number K212433

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HRS 2021-09-21

GEO Extremity and Ankle Plating System

Applicant Gramercy Extremity Orthopedics, LLC

K number K212334

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HRS 2021-08-20

Omni Foot and Ankle Plating System

Applicant Extremity Medical, LLC

K number K212297

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HRS 2021-08-13

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K number K203817

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HRS 2021-07-30

Summit Patella Plating System

Applicant Endeavor Orthopaedics, LLC

K number K203408

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HRS 2021-07-28

FINE Osteotomy

Applicant Bodycad Laboratories, Inc.

K number K211646

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HRS 2021-07-27

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

Applicant Integra LifeSciences Corporation

K number K210016

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HRS 2021-07-16

Avanti Orthopaedics Ulnar Shortening System

Applicant Avanti Orthopaedics, Inc.

K number K211592

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HRS 2021-07-15

Acumed Clavicle Hook Plating System

Applicant Acumed, LLC

K number K210750

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HRS 2021-07-09

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

Applicant Truemed Group, LLC

K number K200575

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HRS 2021-06-29

Smith & Nephew Plates and Screws

Applicant Smith & Nephew, Inc.

K number K210837

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HRS 2021-06-23

Valkyrie Thoracic Fixation System

Applicant Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

K number K211695

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HRS 2021-06-02

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)

Applicant DePuy Synthes

K number K211051

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HRS 2021-05-06

DRPx Locking Distal Radius Plate System

Applicant Orthopaedic Implant Company

K number K202971

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HRS 2021-04-30

JACE Medical Thoracic Plating System

Applicant Jace Medical, LLC

K number K210290

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HRS 2021-04-20

SOLE Medial Column Fusion Plate

Applicant Orthofix Srl

K number K210157

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HRS 2021-04-13

Volition Plating System

Applicant Ortho Solutions UK , Ltd.

K number K210658

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HRS 2021-04-08

DePuy Synthes Variable Angle Locking Patella Plating System

Applicant Synthes (USA) Products, LLC

K number K210408

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HRS 2021-03-26

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Applicant Gramercy Extremity Orthopedics, LLC

K number K210534

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HRS 2021-03-26

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System

Applicant Synthes (USA) Products, LLC

K number K210205

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HRS 2021-03-25

Arthrex Patella SuturePlates

Applicant Arthrex, Inc.

K number K203834

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HRS 2021-03-12

CoLink Mfx Implant System

Applicant In2bones USA, LLC

K number K210060

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HRS 2021-03-08

Versalock Periprosthetic Femur Plates System-GMReis

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K201728

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HRS 2021-03-03

LOQTEQ Distal Lateral Femur Plate 4.5 System

Applicant Aap Implantate AG

K number K210043

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HRS 2021-03-02

Able Medical Devices Valkyrie Thoracic Fixation System

Applicant Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices

K number K202889

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HRS 2021-02-24

ExtremiLOCK Lateral Ankle Fusion Plates

Applicant Osteomed

K number K203479

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HRS 2021-02-22

Foot and Ankle System

Applicant Leith Medical, LLC

K number K200062

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HRS 2021-02-19

A.L.P.S. Clavicle Plating System

Applicant Biomet, Inc.

K number K210192

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HRS 2021-02-03

Arthrex Pilon Fusion System

Applicant Arthrex, Inc.

K number K203294

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HRS 2021-01-28

Biomet Microfixation RibFix Advantage System

Applicant Biomet Micofixation

K number K203474

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HRS 2021-01-27

EVOS Large Fragment Plating System

Applicant Smith & Nephew, Inc.

K number K203405

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HRS 2021-01-08

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

Applicant Wrightmedicaltechnologyinc

K number K201259

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HRS 2020-12-29

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K number K203511

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HRS 2020-12-16

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Applicant DePuy Synthes

K number K203414

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HRS 2020-12-14

Javelin Tailor's Bunion Fixation System

Applicant Nvision Biomedical Technologies, Inc.

K number K202657

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HRS 2020-11-24

PolyLock Plating System

Applicant Fusion Orthopedics, LLC

K number K202959

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HRS 2020-11-20

Ortho Solutions Plating System

Applicant Ortho Solutions UK , Ltd.

K number K202764

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HRS 2020-11-17

Activ Fuse

Applicant Newclip Technics

K number K202307

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HRS 2020-11-16

EVOS Large Fragment Plating System

Applicant Smith & Nephew, Inc.

K number K201918

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HRS 2020-10-29

ARIX Ankle Distal Tibia System

Applicant Jeil Medical Corporation

K number K202912

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HRS 2020-10-29

ANTHEM Fracture System

Applicant Globus Medical, Inc.

K number K202496

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HRS 2020-10-26

AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System

Applicant Advanced Orthopaedic Solutions, Inc.

K number K202489

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HRS 2020-10-13

Skeletal Dynamics Ulnar Shortening Plating System

Applicant Skeletal Dynamics, Inc.

K number K201962

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HRS 2020-10-08

Piccolo Composite Proximal Tibia Plate System

Applicant CarboFix Orthopedics , Ltd.

K number K201917

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HRS 2020-09-15

ARIX Elbow System

Applicant Jeil Medical Corporation

K number K201656

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HRS 2020-09-11

DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Applicant DePuy Synthes

K number K201959

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HRS 2020-09-09

DePuy Synthes Variable Angle Locking Patella Plating System

Applicant Synthes (USA) Products, LLC

K number K201578

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HRS 2020-09-02

Arthrex Mesh Plates

Applicant Arthrex, Inc.

K number K201677

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HRS 2020-07-27

Arthrex Compression Screws

Applicant Arthrex, Inc.

K number K201132

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HRS 2020-07-27

Stratum™ Reduced Size Foot Plating System

Applicant Nextremity Solutions, Inc.

K number K200785

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HRS 2020-07-24

DePuy Synthes 2.7mm VA LCP Clavicle Plate System

Applicant DePuy Synthes

K number K201321

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