Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2010-05-14

VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES

Applicant Howmedica Osteonics Corp.

K number K100271

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HRS 2010-05-13

VARIAX ELBOW SYSTEM

Applicant Howmedica Osteonics Corp.

K number K101056

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HRS 2010-05-11

EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM

Applicant Exactech, Inc.

K number K093978

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HRS 2010-05-11

SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES

Applicant Synthes (Usa)

K number K092812

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HRS 2010-04-30

AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS

Applicant Howmedica Osteonics Corp.

K number K100475

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HRS 2010-04-20

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY

Applicant Orthohelix Surgical Designs, Inc.

K number K100618

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HRS 2010-04-16

PEANUT GROWTH CONTROL PLATING SYSTEM

Applicant Ebi, L.P.

K number K093880

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HRS 2010-04-12

NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Applicant Zimmer, Inc.

K number K100111

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HRS 2010-04-12

DEROYAL NON-LOCKING BONE FIXATION SYSTEM

Applicant Deroyal Industries, Inc.

K number K090975

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HRS 2010-04-08

SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL

Applicant Synthes (Usa)

K number K100676

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HRS 2010-03-29

SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

Applicant Synthes (Usa)

K number K093928

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HRS 2010-03-29

SYNTHES STERNAL FIXATION SYSTEM

Applicant Synthes

K number K093772

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HRS 2010-03-29

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

Applicant Gpc Medical, Ltd.

K number K092493

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HRS 2010-03-19

SMPLE PLATE AND SCREWS

Applicant Biomet Trauma (Aka Ebi, Lp)

K number K093983

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HRS 2010-03-10

TC PLATING SYSTEM

Applicant Ortho-Pro, LLC

K number K094037

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HRS 2010-03-05

OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM

Applicant Biomet Trauma (Aka Ebi, Lp)

K number K093761

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HRS 2010-02-17

EDGELOCK

Applicant Orthohelix Surgical Designs, Inc.

K number K093900

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HRS 2010-02-05

ORTHO SELECT BONE PLATES AND SCREW SYSTEM

Applicant Ortho Select Implant Technology Gesellschaft

K number K091493

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HRS 2010-02-02

EVOLVE EPS ORTHOLOC

Applicant Wrightmedicaltechnologyinc

K number K100146

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HRS 2010-02-02

DEPUY FRACTURE AND FUSION PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K093474

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HRS 2010-01-28

VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

Applicant Howmedica Osteonics Corp.

K number K093433

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HRS 2010-01-22

BIOFOAM BONE WEDGE MODEL ASSORTED

Applicant Wrightmedicaltechnologyinc

K number K093950

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HRS 2010-01-22

MODIFIED: NEWDEAL HALLU PLATES

Applicant Newdeal Sas

K number K093781

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HRS 2009-12-23

SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES

Applicant Synthes (Usa)

K number K091644

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HRS 2009-12-15

INTEGRA TOTAL WRIST FUSION SYSTEM

Applicant Integra LifeSciences Corporation

K number K093163

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HRS 2009-11-20

AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS

Applicant Howmedica Osteonics Corp.

K number K092178

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HRS 2009-11-19

BIODRIVE MICRO SCREW SYSTEM

Applicant Ebi,Llc D/B/A Biomet Trauma

K number K092670

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HRS 2009-11-17

SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)

Applicant Synthes (Usa)

K number K092609

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HRS 2009-11-17

SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS

Applicant Synthes (Usa)

K number K092556

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HRS 2009-11-05

PECTUS STRUT

Applicant Koros USA, Inc.

K number K082399

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HRS 2009-11-02

DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM

Applicant Deroyal Industries, Inc.

K number K092317

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HRS 2009-10-27

IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION

Applicant Ibalance Medical, Inc.

K number K092381

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HRS 2009-10-27

ANKLE ARTHRODESIS PLATE SYSTEM

Applicant Tornier, Inc.

K number K090139

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HRS 2009-09-25

SYNTHES LOCKING HAND PLATES

Applicant Synthes (Usa)

K number K092247

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HRS 2009-09-23

VARIAX ELBOW SYSTEM LINE EXTENSION

Applicant Howmedica Osteonics Corp.

K number K092671

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HRS 2009-09-10

OSTEOMED FOOT PLATING SYSTEM

Applicant Osteomed LP

K number K091614

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HRS 2009-09-01

AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS

Applicant Howmedica Osteonics Corp.

K number K092419

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HRS 2009-08-28

WAVEON WRX BONE FIXATION SYSTEM

Applicant Sonoma Orthopedic Products, Inc.

K number K090304

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HRS 2009-08-05

OPTILOCK PERIARTICULAR PLATING

Applicant Biomet Trauma

K number K092078

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HRS 2009-07-30

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

Applicant Smith & Nephew, Inc.

K number K092015

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HRS 2009-07-24

LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,

Applicant DePuy Orthopaedics, Inc.

K number K091294

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HRS 2009-07-22

ADKINS STRUT

Applicant Biomet Microfixation, Inc.

K number K091058

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HRS 2009-07-15

TRIMED STERILE PRODUCT

Applicant TriMed, Inc.

K number K091156

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HRS 2009-07-13

APTUS FOOT SYSTEM

Applicant Medartis AG

K number K091479

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HRS 2009-07-10

NEWDEAL HALLU LOCK PLATE SYSTEM

Applicant Newdeal Sas

K number K083154

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HRS 2009-07-02

CALCANEAL FRACTURE PLATE SYSTEM

Applicant Tornier, Inc.

K number K090582

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HRS 2009-07-02

OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM

Applicant Osteomed LP

K number K090522

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HRS 2009-07-01

APTUS 2.0/2.3 FOUR CORNER FUSION PLATE

Applicant Medartis AG

K number K090983

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HRS 2009-06-30

NEWDEAL COMPRESSION PLATE

Applicant Newdeal Sas

K number K091609

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HRS 2009-06-26

ORTHOLOC ANKLE PLATING SYSTEM (APS)

Applicant Wrightmedicaltechnologyinc

K number K091243

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HRS 2009-06-26

PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS

Applicant DePuy Orthopaedics, Inc.

K number K090877

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HRS 2009-06-18

KENS INTERNAL FIXATION SYSTEM

Applicant Kens Finemedtech Sdn. Bhd

K number K090786

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HRS 2009-06-15

CLAVICLE PLATING SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K090289

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HRS 2009-06-04

SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES

Applicant Smith & Nephew, Inc.

K number K090675

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HRS 2009-05-20

HINGE PEDIATRIC PLATING SYSTEM

Applicant Pega Medical, Inc.

K number K090440

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HRS 2009-05-08

ORTHOLOC 2.0/2.4 PLATE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K090692

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HRS 2009-04-24

MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS

Applicant Syntec Scientific Corp.

K number K090839

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HRS 2009-04-24

PEDIPLATES

Applicant OrthoPediatrics Corp.

K number K090666

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HRS 2009-04-23

APTUS 2.0 RADIAL HEAD SYSTEM

Applicant Medartis AG

K number K090053

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HRS 2009-04-01

SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM

Applicant Synthes (Usa)

K number K090047

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HRS 2009-03-31

1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS

Applicant DePuy Orthopaedics, Inc.

K number K090492

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HRS 2009-03-20

LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K083843

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HRS 2009-03-06

SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES

Applicant Synthes (Usa)

K number K083694

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HRS 2009-03-04

SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES

Applicant Synthes (Usa)

K number K083573

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HRS 2009-02-26

ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)

Applicant Zimmer, Inc.

K number K083654

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HRS 2009-02-18

ANATOMIC LOCKING PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K082300

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HRS 2009-02-06

MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

Applicant Memometal Technologies

K number K083447

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HRS 2009-01-30

ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM

Applicant OrthoPediatrics Corp.

K number K083286

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HRS 2009-01-14

SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM

Applicant Synthes (Usa)

K number K083025

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HRS 2009-01-07

PERI-LOC BONE PLATING AND SCREW SYSTEM

Applicant Smith & Nephew, Inc.

K number K083032

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HRS 2008-12-30

SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES

Applicant Synthes (Usa)

K number K083213

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HRS 2008-12-19

PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)

Applicant Toby Orthopaedics, LLC

K number K081608

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HRS 2008-12-18

ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS

Applicant Zimmer, Inc.

K number K082527

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HRS 2008-12-17

SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES

Applicant Synthes (Usa)

K number K082625

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HRS 2008-12-11

2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424

Applicant DePuy Orthopaedics, Inc.

K number K083364

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HRS 2008-12-04

MICROWARE BONE PLATES AND BONE SCREWS

Applicant Microware Precision Co., Ltd.

K number K072562

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HRS 2008-11-24

SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS

Applicant Synthes (Usa)

K number K082807

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HRS 2008-11-10

SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES

Applicant Synthes (Usa)

K number K082624

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HRS 2008-11-07

SYNTHES (USA) 3.5MM LCP HOOK PLATE

Applicant Synthes (Usa)

K number K082072

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HRS 2008-11-03

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES

Applicant Zimmer, Inc.

K number K082078

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HRS 2008-10-16

NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V

Applicant Zimmer GmbH

K number K081759

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HRS 2008-09-09

CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE

Applicant Wrightmedicaltechnologyinc

K number K081374

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HRS 2008-09-08

SYNTHES RIB FIXATION SYSTEM

Applicant Synthes (Usa)

K number K081623

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HRS 2008-09-04

AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

Applicant Aesculap Implant Systems, Inc.

K number K080992

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HRS 2008-09-03

RE-ZORB PLATING SYSTEM

Applicant Acute Innovations, LLC

K number K081588

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HRS 2008-08-26

SMALL BONE LOCKING PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K081546

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HRS 2008-08-13

TRAUSON BONE PLATE

Applicant Trauson (Jiangsu) Medical Instrument Co., Ltd.

K number K073432

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HRS 2008-07-23

SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES

Applicant Synthes (Usa)

K number K081353

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HRS 2008-07-22

ORTHOPEDIATRICS PEDIPLATES SYSTEM

Applicant OrthoPediatrics Corp.

K number K081407

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HRS 2008-07-15

ORTHOMESH

Applicant Synthes (Usa)

K number K073115

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HRS 2008-07-03

EVOLVE EPS SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K081373

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HRS 2008-06-24

MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS

Applicant Medxpert GmbH

K number K073556

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HRS 2008-06-18

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139

Applicant Smith & Nephew, Inc.

K number K081106

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HRS 2008-05-23

SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES

Applicant Synthes (Usa)

K number K080522

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HRS 2008-03-26

DISTAL HUMERAL PLATES WITH ANGULAR STABILITY

Applicant I.T.S. Implantat-Technologie-Systeme GmbH

K number K080184

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HRS 2008-03-20

MODULAR FOOT SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K073624

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HRS 2008-03-20

AAP BONE PLATES AND SCREW IMPLANTS

Applicant Aap Implantate AG

K number K072411

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HRS 2008-03-19

VARIAX DISTAL RADIUS TORX SCREWS

Applicant Howmedica Osteonics Corp.

K number K080667

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HRS 2008-02-29

DC ULNAR SHORTENING SYSTEM

Applicant Orthopro, LLC

K number K073228

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HRS 2008-02-27

CHARLOTTE CLAW 3.5

Applicant Wrightmedicaltechnologyinc

K number K080295

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