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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 2012-06-13

MINI MAXLOCK EXTREME PLATING SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K121437

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HRS 2012-06-12

NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE

Applicant Zimmer GmbH

K number K120772

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HRS 2012-06-04

SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM

Applicant Synthes (USA) Products, LLC

K number K120689

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HRS 2012-05-29

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS

Applicant Ortho Solutions Limited

K number K120360

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HRS 2012-05-10

EOS SMALL BONE FIXATION SYSTEM

Applicant TriMed, Inc.

K number K112794

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HRS 2012-05-08

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

Applicant Synthes USA

K number K120717

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HRS 2012-05-03

ORTHOLOC 3DI HALLUX SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K120359

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HRS 2012-05-02

MICROWARE BONE PLATES AND BONE SCREW

Applicant Microware Precision Co., Ltd.

K number K111008

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HRS 2012-04-27

APTUS PROXIMAL HUMERUS SYSTEM

Applicant Medartis AG

K number K120108

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HRS 2012-04-25

VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K113760

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HRS 2012-04-24

OSTEOMED WRIST PLATING SYSTEM

Applicant Osteomed LP

K number K120015

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HRS 2012-04-19

OTIS-C PLUS

Applicant Science For Biomaterials

K number K120818

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HRS 2012-04-10

MINI MAXLOCK EXTREME PLATING SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K120157

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HRS 2012-04-04

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT

Applicant Smith & Nephew, Inc.

K number K120667

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HRS 2012-04-02

ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS

Applicant Wrightmedicaltechnologyinc

K number K120802

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HRS 2012-03-29

LOCKING COMPRESSION PLATE SYSTEM

Applicant Shanghai Microport Orthopedics Co., Ltd.

K number K112798

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HRS 2012-03-23

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX

Applicant Neoortho Produtos Ortopedicos S/A

K number K113733

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HRS 2012-03-21

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

Applicant Synthes USA

K number K120070

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HRS 2012-03-12

ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL

Applicant Enhatch Orthopaedics, LLC

K number K112663

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HRS 2012-03-12

TRAUMA INTERNAL FIXATION SYSTEMS

Applicant DePuy Orthopaedics, Inc.

K number K111663

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HRS 2012-03-12

ADAPTIVE WEDGE

Applicant Adaptive Specialty, LLC

K number K110662

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HRS 2012-02-29

2.7MM LCP ULNA OSTEOTOMY SYSTEM

Applicant Synthes (USA) Products, LLC

K number K113364

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HRS 2012-02-17

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM

Applicant Acute Innovations, LLC

K number K120163

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HRS 2012-02-07

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS

Applicant Ortho Solutions Limited

K number K111678

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HRS 2012-02-06

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM

Applicant Arthrosurface, Inc.

K number K113762

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HRS 2012-01-31

CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS

Applicant Wrightmedicaltechnologyinc

K number K113014

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HRS 2012-01-30

MAXLOCK EXTREME SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K113048

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HRS 2012-01-27

NCB STRAIGHT NARROW SHAFT PLATES

Applicant Zimmer GmbH

K number K113718

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HRS 2012-01-12

ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM

Applicant Acute Innovations, LLC

K number K113318

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HRS 2012-01-11

SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM

Applicant Suspension Orthopaedic Solutions, LLC

K number K113405

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HRS 2012-01-06

APTUS WRIST ARTHRODESIS PLATES

Applicant Medartis AG

K number K112169

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HRS 2011-12-27

SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

Applicant Suspension Orthopaedic Solutions, LLC

K number K112923

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HRS 2011-12-23

STRYKER RESORBABLE FIXATION SYSTEM

Applicant Stryker

K number K113109

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HRS 2011-12-19

AXSOS LOCKING PLATE SYSTEM

Applicant Stryker Corp.

K number K112926

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HRS 2011-12-16

RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW

Applicant Xiamen Double Engline Medical Material Co., Ltd.

K number K112819

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HRS 2011-12-15

APTUS(R) DISTAL HUMERUS SYSTEM

Applicant Medartis AG

K number K112560

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HRS 2011-12-12

ORTHOLOC 3DSI LOCKING SCREWS

Applicant Wrightmedicaltechnologyinc

K number K113339

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HRS 2011-12-06

ASCENSION ATLAS HUMERAL PLATING SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K110700

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HRS 2011-11-17

SYNTHES LCP PEDIATRIC PLATE SYSTEMS

Applicant Synthes (USA) Products, LLC

K number K112085

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HRS 2011-11-14

PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES

Applicant Smith & Nephew, Inc.

K number K112406

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HRS 2011-11-04

TRIMED CLAVICLE FIXATION SYSTEM

Applicant TriMed, Inc.

K number K112509

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HRS 2011-10-26

SYNTHES STERNAL FIXATION SYSTEM

Applicant Synthes, Inc.

K number K112689

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HRS 2011-10-26

NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Applicant Zimmer, Inc.

K number K112174

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HRS 2011-10-24

LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA

Applicant Advanced Orthopaedic Solutions, Inc.

K number K103513

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HRS 2011-10-07

OSTEOMED HAND FUSION SYSTEM

Applicant Osteomed LP

K number K111419

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HRS 2011-10-06

EASYLOCK OSTEOSYSTEM

Applicant TriMed, Inc.

K number K111266

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HRS 2011-09-22

AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K112455

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HRS 2011-09-09

IFS PROFILE PLATES, SCREWS, AND WASHERS

Applicant Internal Fixation Systems, Inc.

K number K110086

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HRS 2011-08-23

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS

Applicant Skeletal Dynamics, LLC

K number K111620

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HRS 2011-08-19

EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS

Applicant Wrightmedicaltechnologyinc

K number K111432

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HRS 2011-08-19

TRIMED RADIOCARPAL FUSION SYSTEM

Applicant TriMed, Inc.

K number K102785

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HRS 2011-08-08

SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

Applicant Synthes (Usa)

K number K111540

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HRS 2011-08-05

ORTHOPEDIATRICS BLADE PLATE SYSTEM

Applicant OrthoPediatrics Corp.

K number K110959

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HRS 2011-08-02

ARTHREX DISTAL EXTREMITY PLATE SYSTEM

Applicant Arthrex, Inc.

K number K111253

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HRS 2011-07-22

MAESTRO WRIST PLATING SYSTEM

Applicant Biomet Manufacturing Corp

K number K110271

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HRS 2011-07-21

COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM

Applicant Biomet Manufacturing Corp

K number K110320

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HRS 2011-07-21

EXPLOR RADIAL HEAD PLATING SYSTEM

Applicant Biomet, Inc.

K number K110201

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HRS 2011-07-12

VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES

Applicant Smith & Nephew, Inc.

K number K110670

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HRS 2011-07-06

OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM

Applicant Graham Medical Technologies, LLC

K number K111326

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HRS 2011-06-28

APTUS FOOT 3.5 SYSTEM

Applicant Medartis AG

K number K110908

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HRS 2011-06-17

ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM

Applicant OrthoPediatrics Corp.

K number K111086

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HRS 2011-06-06

MINI VARIABLE SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K111041

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HRS 2011-05-19

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM

Applicant Zimmer, Inc.

K number K111039

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HRS 2011-05-18

BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

Applicant Biomet Microfixation, Inc.

K number K110574

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HRS 2011-05-13

MAHE FIXATION PLATE AND SCREW SYSTEM

Applicant Mahe Medical GmbH

K number K102845

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HRS 2011-04-21

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

Applicant Synthes USA

K number K110125

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HRS 2011-04-14

NEWDEAL COMPRESSION PLATES

Applicant Newdeal Sas

K number K093914

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HRS 2011-03-18

AXSOS (TM) LOCKING PLATE SYSTEM

Applicant Stryker Corp.

K number K110476

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HRS 2011-03-15

MEMOMETAL NAVIS BONE PLATING SYSTEM

Applicant Memometal Technologies

K number K101930

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HRS 2011-02-24

PICCOLO COMPOSITE PLATE SYSTEM

Applicant N.M.B. Medical Applications, Ltd.

K number K102597

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HRS 2011-02-15

AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K110176

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HRS 2011-01-24

APTUS ULNA PLATES

Applicant Medartis AG

K number K103332

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HRS 2011-01-21

2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

Applicant Synthes (Usa)

K number K103243

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HRS 2011-01-04

CONGRUENT BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K102998

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HRS 2010-12-16

POSTERIOR LATERAL PLATES

Applicant DePuy Orthopaedics, Inc.

K number K103408

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HRS 2010-12-15

CONTOURS LAPIDUS PLATING SYSTEM

Applicant Orthofix, Inc.

K number K102201

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HRS 2010-12-10

APTUS 1.5 TRILOCK

Applicant Medartis AG

K number K102537

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HRS 2010-12-09

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

Applicant Synthes (Usa)

K number K102694

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HRS 2010-12-07

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K102282

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HRS 2010-12-07

SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

Applicant Suspension Orthopaedic Solutions, LLC

K number K102095

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HRS 2010-12-02

EVOLVE EPS ORTHOLOC

Applicant Wrightmedicaltechnologyinc

K number K102352

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HRS 2010-11-24

HTO PLATING SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K102505

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HRS 2010-11-23

ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW

Applicant Wrightmedicaltechnologyinc

K number K102429

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HRS 2010-11-09

LOCKING COMPRESSION PLATE

Applicant Changzhou Orthmed Medical Instrument Co., Ltd.

K number K101400

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HRS 2010-10-22

CLAVICLE LOCKING PLATE SYSTEM

Applicant Newclip Technics

K number K100944

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HRS 2010-10-20

CONTOURS VSP III VOLAR PLATING SYSTEM

Applicant Orthofix, Inc.

K number K101936

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HRS 2010-10-06

ACUMED WRIST ARTHRODESIS PLATE SYSTEM

Applicant Acumed, LLC

K number K100123

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HRS 2010-09-30

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS

Applicant Orthohelix Surgical Designs, Inc.

K number K102156

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HRS 2010-09-27

MINI MAXLOCK EXTREME PLATING SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K101962

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HRS 2010-09-15

2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

Applicant Synthes (Usa), LLC

K number K101536

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HRS 2010-08-05

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM

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

K number K093868

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HRS 2010-08-03

SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM

Applicant Synthes (Usa)

K number K100776

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HRS 2010-08-02

ASCENSION TOTAL PLATE SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K100502

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HRS 2010-07-23

CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467

Applicant DePuy Orthopaedics, Inc.

K number K101240

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HRS 2010-06-25

SYNTEC OSTEO-PLATE AND SCREW FIXATION

Applicant Syntec Scientific Corp.

K number K092889

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HRS 2010-06-16

ASCENSION ANKLE FUSION PLATE SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K100176

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HRS 2010-06-15

MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204

Applicant DePuy Orthopaedics, Inc.

K number K101421

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HRS 2010-06-14

OTIS -C PLUS

Applicant Sciences ET Bio Materiaux (Sbm)

K number K100604

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HRS 2010-05-21

BIOMET FORERUNNER LOCKING PLATE SYSTEM

Applicant Biomet Trauma (Aka Ebi, Lp)

K number K092528

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HRS 2010-05-17

ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM

Applicant OrthoPediatrics Corp.

K number K100240

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