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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 2016-05-17

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

Applicant Gpc Medical, Ltd.

K number K153716

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HRS 2016-05-17

BIOFOAM Bone Wedge

Applicant Wrightmedicaltechnologyinc

K number K152062

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HRS 2016-04-22

G3(TM) Active Plate(R) Small Fragment System

Applicant Genesis Fracture Care, Inc.

K number K160633

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HRS 2016-04-22

MotoBand(TM) CP Implant System

Applicant Crossroads Extremity Systems, LLC

K number K160300

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HRS 2016-04-22

Gridlock Ankle Plating System

Applicant Trilliant Surgical, Ltd.

K number K160177

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HRS 2016-04-06

KLS Martin Thoracic Plating System

Applicant KLS-Martin L.P.

K number K153482

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HRS 2016-03-25

Align Anterior Ankle Fusion Plate

Applicant Extremity Medical, LLC

K number K160191

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HRS 2016-03-24

Biomet Microfixation RibFix Blu Thoracic Fixation System

Applicant Biomet Microfixation

K number K152253

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HRS 2016-03-09

Piccolo Composite(R) Distal Volar Radius Plate System

Applicant CarboFix Orthopedics , Ltd.

K number K160002

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HRS 2016-02-25

IRENE Locking Compression Plate System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K number K151508

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HRS 2016-02-09

Epic Extremity Plate System

Applicant Epic Extremity, LLC

K number K153340

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HRS 2016-01-29

TriMed Humeral Supracondylar Fixation System

Applicant TriMed, Inc.

K number K151735

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HRS 2016-01-28

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System

Applicant Zimmer, Inc.

K number K151716

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HRS 2016-01-21

aap LOQTEQ VA Radius Set 2.5

Applicant Aap Implantate AG

K number K153034

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HRS 2016-01-14

ARIX Wrist System

Applicant Jeil Medical Corporation

K number K151468

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HRS 2016-01-07

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K number K153531

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HRS 2013-12-24

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE

Applicant Aap Implantate AG

K number K132787

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HRS 2013-12-18

ARIX HAND LOCKING SYSTEM

Applicant Jeil Medical Corporation

K number K132876

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HRS 2013-12-17

ZIMMER DISTAL RADIUS PLATING SYSTEM

Applicant Zimmer, Inc.

K number K133246

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HRS 2013-12-13

CROSSCHECK PLATING SYSTEM

Applicant Solana Surgical, LLC

K number K132594

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HRS 2013-12-02

1ST MTP PLATE

Applicant Osteomed

K number K133437

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HRS 2013-11-19

A.L.P.S. CALCANEAL PLATING SYSTEM

Applicant Biomet Manufacturing Corp

K number K132898

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HRS 2013-11-18

FLOWER ANKLE PLATING SET

Applicant Flower Orthopedics Corporation

K number K133102

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HRS 2013-11-18

LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5

Applicant Aap Implantate AG

K number K131782

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HRS 2013-11-04

WOLF LONG BONE PLATE SYSTEM

Applicant Toby Orthopaedics

K number K131834

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HRS 2013-11-04

ARIX HAND SYSTEM

Applicant Jeil Medical Corporation

K number K131566

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HRS 2013-10-29

2.5MM INLINE FUSION PLATE

Applicant Biomet, Inc.

K number K131867

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HRS 2013-10-23

VARIAX 2 SYSTEM

Applicant Stryker Trauma AG

K number K132502

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HRS 2013-10-08

SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM

Applicant Synthes (USA) Products, LLC

K number K131186

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HRS 2013-10-03

LOCKING PLATE SYSTEM

Applicant Beijing Libeier Bio-Engineering Institute Co., Ltd.

K number K132642

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HRS 2013-10-03

AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5

Applicant Aap Implantate AG

K number K132554

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HRS 2013-09-25

ARTHREX COMPRESSION PLATES

Applicant Arthrex, Inc.

K number K130510

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HRS 2013-09-17

MAXLOCK EXTREME SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K132591

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HRS 2013-09-05

ACUMED WRIST SPANNING PLATE

Applicant Acumed, LLC

K number K131764

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HRS 2013-09-05

ARIX FOOT SYSTEM

Applicant Jeil Medical Corporation

K number K131311

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HRS 2013-08-22

FLOWER SMALL AND MEDIUM IMPLANT SET

Applicant Flower Orthopedics Corporation

K number K131657

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HRS 2013-08-09

METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT

Applicant Merete Medical GmbH

K number K132226

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HRS 2013-08-08

METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM

Applicant Tianjin Walkman Biomaterial Co., Ltd.

K number K131759

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HRS 2013-08-07

I.T.S. EXTREMITY FIXATION SYSTEMS

Applicant I.T.S. GmbH

K number K131722

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HRS 2013-08-07

INTEGRA TITANIUM BONE WEDGE

Applicant Ascension Orthopedic

K number K131360

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HRS 2013-08-02

NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0

Applicant Normed Medizin-Technik GmbH

K number K123347

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HRS 2013-07-19

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW

Applicant Stabiliz Orthopaedics, LLC

K number K130731

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HRS 2013-07-03

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)

Applicant Biomet, Inc.

K number K131670

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HRS 2013-07-03

EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM

Applicant Emerge Medical

K number K131480

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HRS 2013-07-03

ARTHREX DISTAL RADIUS PLATE SYSTEM

Applicant Arthrex, Inc.

K number K131474

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HRS 2013-06-25

DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING

Applicant I.T.S. GmbH

K number K130008

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HRS 2013-06-19

UNIVERSAL DISTAL RADIUS SYSTEM

Applicant Newclip Technics

K number K130774

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HRS 2013-06-18

OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM

Applicant Osteomed LP

K number K131445

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HRS 2013-06-10

ACUMED TOTALW RIST FUSION PLATING SYSTEM

Applicant Acumed, LLC

K number K131380

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HRS 2013-06-07

4WEB OSTEOTOMY BONE WEDGE

Applicant 4-Web, Inc.

K number K130185

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HRS 2013-05-31

PELVIS II IMPLANT SYSTEM

Applicant Stryker Trauma AG

K number K131132

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HRS 2013-05-21

ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K131093

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HRS 2013-05-08

GRIDLOCK PLATING SYSTEM

Applicant Trilliant Surgical, Ltd.

K number K130964

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HRS 2013-04-19

DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS

Applicant Xiamen Double Engine Medical Material Co., Ltd.

K number K130108

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HRS 2013-04-05

LOCKING BONE PLATES AND SCREWS

Applicant Weigao Orthopaedic Device Co., Ltd.

K number K130340

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HRS 2013-04-05

ARTHREX FRACTURE PLATES

Applicant Arthrex, Inc.

K number K123241

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HRS 2013-03-29

FLOWER SMALL AND MEDIUM BONE IMPLANTS

Applicant Flower Orthopedics Corporation

K number K123562

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HRS 2013-03-28

AXSOS 3 TI LOCKING PLATE SYSTEM

Applicant Stryker Trauma AG

K number K123964

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HRS 2013-03-28

BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831

Applicant Biomet Manufacturing Corp

K number K122770

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HRS 2013-03-22

VARIAX 2 COMPRESSION PLATING SYSTEM

Applicant Stryker Trauma AG

K number K130009

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HRS 2013-03-20

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME

Applicant The Orthopaedic Implant Company (Oic)

K number K123832

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HRS 2013-03-20

AXSOS PROXIMAL LATERAL TIBIA LONG PLATES

Applicant Stryker Trauma AG

K number K123403

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HRS 2013-03-11

AAP RADIUS SET 2.5

Applicant Aap Implantate AG

K number K123875

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HRS 2013-03-05

SUPERIOR LATERAL VARIAX CLAVICLE PLATE

Applicant Stryker Trauma AG

K number K130116

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HRS 2013-02-28

ANKLE TRAUMA SYSTEM

Applicant Orthopro, LLC

K number K122936

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HRS 2013-02-27

PICCOLO COMPOSITE PLATE SYSTEM

Applicant CarboFix Orthopedics , Ltd.

K number K130061

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HRS 2013-02-15

GRIDLOCK PLATING SYSTEM

Applicant Trilliant Surgical, Ltd.

K number K123525

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HRS 2013-02-14

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM

Applicant Zimmer, Inc.

K number K123918

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HRS 2013-02-13

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K121826

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HRS 2013-01-25

SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION

Applicant Smith & Nephew, Inc.

K number K123055

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HRS 2013-01-18

GEMINUS FOSSA SPECIFIC PLATE SYSTEM

Applicant Skeletal Dynamics, LLC

K number K122310

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HRS 2013-01-17

CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM

Applicant Conventus Orthopaedics

K number K102689

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HRS 2012-12-21

INTEGRA TOTAL FOOT SYSTEMS

Applicant Integra LifeSciences Corporation

K number K123000

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HRS 2012-12-14

MAXLOCK EXTREME SYSTEM MODEL MXL

Applicant Orthohelix Surgical Designs, Inc.

K number K123203

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HRS 2012-12-07

LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG

Applicant Aap Implantate AG

K number K121495

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HRS 2012-11-28

CHECKMATE SMALL BONE FUSION SYSTEM

Applicant Arthrosurface, Inc.

K number K122334

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HRS 2012-11-27

MERETE LOCKING BONE PLATE SYSTEM III

Applicant Merete Medical GmbH

K number K120787

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HRS 2012-11-27

STABILIZ FIXATION SYSTEM

Applicant Stabiliz Orthopaedics, LLC

K number K120651

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HRS 2012-11-26

PICCOLO COMPOSITE PLATE SYSTEM

Applicant CarboFix Orthopedics , Ltd.

K number K120409

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HRS 2012-11-19

ACUMED PELVIC BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K122538

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HRS 2012-11-19

LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING

Applicant Aap Implantate AG

K number K121494

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HRS 2012-11-14

KLS MARTIN RECON TALON

Applicant KLS Martin L.P.

K number K122860

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HRS 2012-11-08

AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM

Applicant Aap Implantate AG

K number K113601

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HRS 2012-10-31

AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM

Applicant Aap Implantate AG

K number K113602

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HRS 2012-10-12

PIONEER STERNAL CABLE PLATE SYSTEM

Applicant Pioneer Surgical Technology, Inc.

K number K122293

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HRS 2012-10-12

ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K121651

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HRS 2012-10-03

GEMINUS FOSSA SPECIFIC PLATE SYSTEM

Applicant Skeletal Dynamics, LLC

K number K122737

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HRS 2012-10-01

AXSOS DISTAL LATERAL FEMUR TS LONG PLATES

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K122308

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HRS 2012-10-01

AFT PROXIMAL HUMERUS FRACTURE PLATE

Applicant Shoulder Options, Inc.

K number K121672

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HRS 2012-10-01

ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K121425

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HRS 2012-09-26

SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT

Applicant Advanced Orthopaedic Solutions, Inc.

K number K122623

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HRS 2012-09-19

BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

Applicant Biomet Microfixation

K number K121302

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HRS 2012-09-06

MAXLOCK EXTREME SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K122005

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HRS 2012-09-06

LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF

Applicant Aap Implantate AG

K number K113648

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HRS 2012-08-30

LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T

Applicant Aap Implantate AG

K number K113652

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HRS 2012-08-20

GRIDLOCK PLATING SYSTEM

Applicant Trilliant Surgical, Ltd.

K number K121452

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HRS 2012-07-26

PIONEER STERNAL ASSIST IMPLANT SYSTEM

Applicant Pioneer Surgical Technology, Inc.

K number K120016

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HRS 2012-07-13

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

Applicant Acumed, LLC

K number K120903

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HRS 2012-07-06

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE

Applicant Synthes USA

K number K121601

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HRS 2012-06-18

SYNTHES VA LCP ANKLE TRAUMA SYSTEM

Applicant Synthes USA

K number K120854

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