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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 2005-08-08

MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005

Applicant Kapp Surgical Instrument, Inc.

K number K050655

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HRS 2005-08-05

CHARLOTTE SMALL MTP FUSION PLATE

Applicant Wrightmedicaltechnologyinc

K number K051884

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HRS 2005-07-27

OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES

Applicant TriMed, Inc.

K number K050681

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HRS 2005-07-21

ACUMED RIB CONGRIENT BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K051410

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HRS 2005-07-19

PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY

Applicant Smith & Nephew, Inc.

K number K051735

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HRS 2005-07-11

HUMERAL HEAD PLATE WITH ANGULAR STABILITY

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

K number K051412

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HRS 2005-07-11

SOLCO 4CIS GENERAL PLATE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K051155

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HRS 2005-06-22

CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM

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

K number K050852

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HRS 2005-05-27

MAXLOCK

Applicant Orthohelix Surgical Designs, Inc.

K number K050868

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HRS 2005-05-23

CUSTOM-HIP TOOL

Applicant Orthopedic Sciences, Inc.

K number K051181

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HRS 2005-05-23

TITANIUM-HIP TOOL

Applicant Orthopedic Sciences, Inc.

K number K051032

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HRS 2005-05-12

ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K051083

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HRS 2005-04-26

SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

Applicant Synthes (Usa)

K number K050646

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HRS 2005-04-26

SBI HAND FIXATION SYSTEM (TM)

Applicant Small Bone Innovations, LLC

K number K050462

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HRS 2005-04-15

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10

Applicant Zimmer Trabecular

K number K050101

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HRS 2005-04-11

SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)

Applicant Synthes (Usa)

K number K050607

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HRS 2005-03-21

STRYKER LOCKED PLATING SYSTEM

Applicant Howmedica Osteonics Corp.

K number K050512

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HRS 2005-03-14

INTEGRA BONE FIXATION SYSTEM

Applicant Integra Lifesciences Corp.

K number K050492

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HRS 2005-03-04

SYNTHES (USA) LCP MODULAR FOOT PLATES

Applicant Synthes (Usa)

K number K050110

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HRS 2005-01-31

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359

Applicant Zimmer, Inc.

K number K050121

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HRS 2005-01-21

PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359

Applicant Zimmer, Inc.

K number K043560

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HRS 2005-01-14

TRIMED OSTEOTOMY PLATE

Applicant TriMed, Inc.

K number K043263

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HRS 2004-12-10

PERIARTICULAR LOCKING PLATES, 2358 SERIES

Applicant Zimmer, Inc.

K number K043227

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HRS 2004-11-16

ORTHOFIX VOLAR DISTAL RADIAL PLATE

Applicant Orthofix, Inc.

K number K042766

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HRS 2004-10-29

NCB PLATING SYSTEM

Applicant Zimmer GmbH

K number K042695

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HRS 2004-10-29

PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES

Applicant Zimmer, Inc.

K number K042598

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HRS 2004-10-27

SYNTHES (USA) LCP WRIST FUSION PLATES

Applicant Synthes (Usa)

K number K042355

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HRS 2004-10-08

DORSAL INTRAMEDULLARY PLATE

Applicant Deo Volente Orthopaedics, LLC

K number K042437

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HRS 2004-10-07

SYNTHES LOW PROFILE RECONSTRUCTION PLATES

Applicant Synthes (Usa)

K number K042377

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HRS 2004-09-20

BONE FUSION PLATE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K042205

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HRS 2004-09-16

EBI PERIARTICULAR PLATING SYSTEM

Applicant Ebi, L.P.

K number K042237

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HRS 2004-09-08

ARTHREX HUMERAL FRACTURE PLATES AND SCREWS

Applicant Arthrex, Inc.

K number K041965

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HRS 2004-09-08

SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG

Applicant Synthes (Usa)

K number K041860

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HRS 2004-09-08

CALCAMEA PLATE

Applicant New Deal, S.A.

K number K041786

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HRS 2004-08-27

SURFIX KNEE OSTEOTOMY SYSTEM

Applicant Surfix Technologies

K number K041601

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HRS 2004-08-16

KMI DISTAL VOLAR RADIUS PLATE SYSTEM

Applicant Kinetikos Medical, Inc.

K number K041461

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HRS 2004-08-16

EBI LACTOSORB GRAFT CONTAINMENT SYSTEM

Applicant Ebi, L.P.

K number K033918

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HRS 2004-07-01

RADIAL NAIL SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K040938

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HRS 2004-07-01

ARTHREX SMALL FRAGMENT PLATES AND SCREWS

Applicant Arthrex, Inc.

K number K040907

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HRS 2004-06-25

EBI DISTAL RADIUS PLATING SYSTEM

Applicant Ebi, L.P.

K number K040908

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HRS 2004-06-24

TSY SHOULDER PLATE IMPLANT

Applicant Orthopedic Sciences, Inc.

K number K040850

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HRS 2004-06-24

WAFER SYSTEM

Applicant Spine Wave, Inc.

K number K033303

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HRS 2004-06-18

LCP RADIAL HEAD PLATING SYSTEM

Applicant Synthes (Usa)

K number K040777

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HRS 2004-06-17

INTEGRA BONE FIXATION SYSTEM

Applicant Integra LifeSciences Corporation

K number K040860

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HRS 2004-05-13

KLS MARTIN HAND PLATING SYSTEM

Applicant KLS-Martin L.P.

K number K040598

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HRS 2004-05-07

SYNTHES (USA) 2.4 MM LCP WRIST PLATE

Applicant Synthes (Usa)

K number K040588

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HRS 2004-04-12

PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES

Applicant Zimmer, Inc.

K number K040593

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HRS 2004-03-12

TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE

Applicant Tri-Med, Inc.

K number K040112

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HRS 2004-03-12

STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM

Applicant Stryker Leibinger

K number K040022

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HRS 2004-03-01

INION OTPS BIODEGRADABLE MESH PLATING SYSTEM

Applicant Inion , Ltd.

K number K031961

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HRS 2004-02-06

VOLAR RADIUS PLATE WITH ANGULAR STABILITY

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

K number K033756

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HRS 2004-02-05

TRIMED RADIAL BULLET

Applicant Tri-Med, Inc.

K number K030877

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HRS 2004-01-28

EVOLVE RADIAL PLATE

Applicant Wrightmedicaltechnologyinc

K number K033456

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HRS 2003-12-10

SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)

Applicant Smith & Nephew, Inc.

K number K033669

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HRS 2003-12-05

CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET

Applicant Biomet, Inc.

K number K033519

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HRS 2003-11-20

GROWTH GUIDANCE PLATE

Applicant University of Utah/School of Medicine

K number K031493

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HRS 2003-11-18

ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS

Applicant Arthrex, Inc.

K number K031666

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HRS 2003-10-22

SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS

Applicant Synthes (Usa)

K number K032559

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HRS 2003-10-10

KLS-MARTIN STERNAL PLATING SYSTEM

Applicant KLS-Martin L.P.

K number K032413

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HRS 2003-09-22

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM

Applicant Arthrex, Inc.

K number K032187

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HRS 2003-09-17

SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

Applicant Synthes (Usa)

K number K032269

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HRS 2003-09-04

SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

Applicant Synthes (Usa)

K number K032032

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HRS 2003-08-21

SYNTHES (USA) CALVICLE HOOK PLATE

Applicant Synthes (Usa)

K number K031677

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HRS 2003-06-09

SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM

Applicant Swiss Orthopedic Solutions, Inc.

K number K031609

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HRS 2003-05-22

TEXAS T - PLATE

Applicant Biomet, Inc.

K number K031334

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HRS 2003-05-05

SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES

Applicant Synthes (Usa)

K number K031178

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HRS 2003-04-22

SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM

Applicant Synthes (Usa)

K number K030310

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HRS 2003-04-10

AAP ACROPLATE

Applicant Aap Implantate AG

K number K030909

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HRS 2003-04-10

AVANTA CARPAL FUSION PLATING SYSTEM

Applicant Avanta Orthopaedics, Inc.

K number K030881

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HRS 2003-04-04

SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS

Applicant Synthes (Usa)

K number K030858

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HRS 2003-04-01

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM

Applicant Hand Innovations, Inc.

K number K030198

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HRS 2003-03-20

SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES

Applicant Synthes (Usa)

K number K030597

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HRS 2003-02-05

SMALL TITANIUM WRIST FUSION PLATE

Applicant Synthes (Usa)

K number K023879

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HRS 2003-01-28

SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM

Applicant Synthes (Usa)

K number K023802

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HRS 2002-12-05

DISTAL RADIUS FRACTURE REPAIR SYSTEM

Applicant Hand Innovations, Inc.

K number K023007

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HRS 2002-09-23

HIP TOOL IMPLANT

Applicant Orthopedic Sciences, Inc.

K number K022139

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HRS 2002-09-17

BIOMET CALCANEAL PLATE

Applicant Biomet Orthopedics, Inc.

K number K022515

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HRS 2002-09-17

NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM

Applicant Osteomedics, Inc.

K number K022324

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HRS 2002-09-13

NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM

Applicant Osteomedics, Inc.

K number K022231

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HRS 2002-09-10

NORMED MINI EXTERNAL FIXATOR SYSTEM

Applicant Osteomedics, Inc.

K number K022230

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HRS 2002-09-09

NORMED TITANIUM OSTEOTOMY PLATING SYSTEM

Applicant Osteomedics, Inc.

K number K022325

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HRS 2002-09-09

NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM

Applicant Osteomedics, Inc.

K number K022323

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HRS 2002-08-12

HALLU PLATES

Applicant New Deal, S.A.

K number K021626

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HRS 2002-07-25

MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES

Applicant Synthes (Usa)

K number K022255

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HRS 2002-07-24

SYNTHES IN-SITU BENDER/CUTTER

Applicant Synthes (Usa)

K number K021458

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HRS 2002-07-17

WRIST FUSION PLATE

Applicant Acu Med, Inc.

K number K021321

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HRS 2002-07-01

MACROPORE OS TRAUMA

Applicant Macropore Biosurgery, Inc.

K number K021164

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HRS 2002-06-12

SYNTHES 3.5 MM BROAD LC-DCP PLATES

Applicant Synthes (Usa)

K number K020872

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HRS 2002-05-20

SYNTHES PILON PLATE

Applicant Synthes

K number K020602

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HRS 2002-05-08

SYNTHES CALCANEAL PLATE

Applicant Synthes (Usa)

K number K020401

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HRS 2002-04-22

DISTAL RADIUS PLATING SYSTEM

Applicant Biomet, Inc.

K number K020819

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HRS 2002-04-02

IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET

Applicant Biomet Orthopedics, Inc.

K number K020221

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HRS 2002-03-27

UNIVERSAL BONE PLATE III SYSTEM (UBP III)

Applicant Spinal Concepts, Inc.

K number K020611

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HRS 2002-03-21

SYNTHES HIGH TIBIAL OSTEOTOMY PLATE

Applicant Synthes (Usa)

K number K014197

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HRS 2002-03-18

OPENING/CLOSING WEDGE OSTETOMY PLATES

Applicant Arthrex, Inc.

K number K014155

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HRS 2002-01-11

SYNTHES ANKLE ARTHRODESIS PLATE

Applicant Synthes (Usa)

K number K013415

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HRS 2002-01-08

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

Applicant Stryker Leibinger

K number K013775

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HRS 2001-12-20

LORENZ LACTOSORB PANELS AND FASTENERS

Applicant Biomet, Inc.

K number K011139

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HRS 2001-12-19

SYNTHES LCP DISTAL TIBIA PLATES

Applicant Synthes (Usa)

K number K013248

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HRS 2001-12-03

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES

Applicant Biomet Orthopedics, Inc.

K number K013657

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