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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 2008-02-21

SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES

Applicant Synthes (Usa)

K number K073460

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HRS 2008-02-21

NEWDEAL TIBIAXYS SYSTEM

Applicant Newdeal Sas

K number K073375

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HRS 2008-02-21

ENSPLINTRX BONE FIXATION SYSTEM

Applicant Sonoma Orthopedic Products, Inc.

K number K071809

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HRS 2008-02-19

ORTHOPEDIATRICS PLATING SYSTEM

Applicant Orthopediatrics, LLC

K number K073344

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HRS 2008-01-07

BIOFOAM BONE WEDGE

Applicant Wrightmedicaltechnologyinc

K number K073535

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HRS 2007-12-17

SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

Applicant Synthes (Usa)

K number K073186

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HRS 2007-12-14

ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K072832

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HRS 2007-11-19

PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS

Applicant Smith & Nephew, Inc.

K number K072818

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HRS 2007-11-19

MONDEAL EXTREMITY BONE FIXATION SYSTEM

Applicant Mondeal Medical Systems GmbH

K number K072740

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HRS 2007-11-07

4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.

Applicant DePuy Orthopaedics, Inc.

K number K072423

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HRS 2007-10-25

SMALL FRAGMENT LOCKING PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K072083

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HRS 2007-10-05

SMALL BONE WEDGE

Applicant Wrightmedicaltechnologyinc

K number K070592

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HRS 2007-09-17

MONDEAL DISTAL RADIUS SYSTEM

Applicant Mondeal Medical Systems GmbH

K number K071798

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HRS 2007-09-17

MONDEAL HAND CONTOUR SYSTEM

Applicant Mondeal Medical Systems GmbH

K number K071797

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HRS 2007-09-06

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

Applicant Biomet Microfixation, Inc.

K number K071577

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HRS 2007-08-21

TITANIUM HIP TOOL LOCKING PLATE

Applicant Orthopedic Sciences, Inc.

K number K072175

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HRS 2007-08-08

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

Applicant Smith & Nephew, Inc.

K number K071563

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HRS 2007-08-07

SBI RHEAD PLATING SYSTEM

Applicant Small Bone Innovations, Inc.

K number K071549

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HRS 2007-07-30

OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM

Applicant Osteomed LP

K number K071105

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HRS 2007-07-27

DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)

Applicant Terray Corp.

K number K063275

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HRS 2007-07-26

BIOMET VARIABLE LOCKING PLATE SYSTEM

Applicant Biomet Trauma

K number K071325

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HRS 2007-07-18

ACUMED CONGRUENT BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K071715

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HRS 2007-07-09

SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE

Applicant Synthes (Usa)

K number K071264

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HRS 2007-06-22

SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM

Applicant Synthes (Usa)

K number K071184

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HRS 2007-06-06

SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES

Applicant Synthes (Usa)

K number K070946

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HRS 2007-05-30

SBI DISTAL RADIUS VOLAR PLATING SYSTEM

Applicant Small Bone Innovations, Inc.

K number K070793

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HRS 2007-05-07

GROWTH CONTROL PLATING SYSTEM

Applicant Biomet Trauma

K number K070823

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HRS 2007-03-29

NEWDEAL COMPRESSION PLATE

Applicant Newdeal Sas

K number K070447

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HRS 2007-03-28

SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES

Applicant Synthes (Usa)

K number K070208

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HRS 2007-03-26

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE

Applicant KLS Martin L.P.

K number K070169

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HRS 2007-03-15

STRYKER FOOT PLATING SYSTEM

Applicant Howmedica Osteonics Corp.

K number K063875

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HRS 2007-03-06

PLC SUTURE ANCHOR

Applicant Smith & Nephew Inc., Endoscopy Div.

K number K063726

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HRS 2007-03-02

DALL-MILES SYSTEM

Applicant Stryker Orthopaedics

K number K070170

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HRS 2007-02-08

MODIFICATION TO LAPIDUS PLATE

Applicant New Deal, S.A.

K number K070241

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HRS 2007-02-08

MODIFICATION TO TTC PLATES

Applicant New Deal, S.A.

K number K070160

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HRS 2007-02-08

LISFRANC PLATE

Applicant New Deal, S.A.

K number K063820

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HRS 2007-02-07

BASAL DORSAL PLATES

Applicant Newdeal Sas

K number K063831

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HRS 2007-02-02

FIBULA PLATE PROLOCK WITH ANGULAR STABILITY

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

K number K063672

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HRS 2007-01-23

INION CPS/OTPS FREEDOMPLATE

Applicant Inion , Ltd.

K number K063410

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HRS 2007-01-04

TS-BONE HIP TOOL

Applicant Orthopedic Sciences, Inc.

K number K063709

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HRS 2006-12-27

FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)

Applicant Praesidia S.R.L.

K number K063009

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HRS 2006-12-22

I.T.S. PELVIC RECONSTRUCTION SYSTEM

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

K number K063166

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HRS 2006-12-22

HUMERUS LOCKING PLATING SYSTEM

Applicant Newclip Technics

K number K063095

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HRS 2006-12-18

LORENZ STERNAL CLOSURE SYSTEM

Applicant Walter Lorenz Surgical, Inc.

K number K063506

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HRS 2006-12-18

SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM

Applicant Synthes (Usa)

K number K063049

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HRS 2006-12-14

INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM

Applicant Intai Technology, Inc.

K number K063020

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HRS 2006-12-07

ACUMED CONGRUENT BONE PLATE SYSTEM

Applicant Acumed, LLC

K number K063460

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HRS 2006-11-22

UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS

Applicant Zimmer, Inc.

K number K063303

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HRS 2006-11-01

MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT

Applicant Orthopedic Sciences, Inc.

K number K063033

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HRS 2006-10-25

PROFYLE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K062498

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HRS 2006-10-20

SBI CARPAL FUSION PLATE

Applicant Small Bone Innovations, Inc.

K number K062903

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HRS 2006-10-19

SYNTHES LCP DISTAL FEMUR PLATES

Applicant Synthes (Usa)

K number K062564

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HRS 2006-10-19

EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM

Applicant Ebi, L.P.

K number K062494

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HRS 2006-09-29

ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM

Applicant Arthrex, Inc.

K number K062747

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HRS 2006-09-15

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

Applicant Smith & Nephew, Inc.

K number K062216

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HRS 2006-09-11

SYNTHES 3.5MM SPRING PLATE

Applicant Synthes (Usa)

K number K061973

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HRS 2006-09-08

SYNTHES LCP ANKLE ARTHRODESIS PLATES

Applicant Synthes (Usa)

K number K061940

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HRS 2006-09-07

KLS MARTIN STERNAL TALON

Applicant KLS-Martin L.P.

K number K051165

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HRS 2006-08-28

DISTAL RADIUS LOCKING PLATING SYSTEM

Applicant Newclip Technics

K number K061917

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HRS 2006-08-17

DARCO LOCKING BONE PLATE SYSTEM

Applicant Darco International, Inc.

K number K061808

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HRS 2006-08-04

RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS

Applicant Creative Medical Designs, Inc.

K number K061955

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HRS 2006-08-04

SYNTHES (USA) CLAVICLE HOOK PLATES

Applicant Synthes (Usa)

K number K061753

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HRS 2006-08-03

LISFRANC PLATE

Applicant New Deal, S.A.

K number K060474

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HRS 2006-07-17

MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

Applicant Medicon EG

K number K053624

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HRS 2006-06-29

CALCANEAL TRAUMA SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K061400

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HRS 2006-06-14

NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

Applicant Zimmer GmbH

K number K061211

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HRS 2006-06-08

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY

Applicant Smith & Nephew, Inc.

K number K061352

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HRS 2006-06-06

LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM

Applicant Walter Lorenz Surgical, Inc.

K number K061384

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HRS 2006-05-24

EBI OPTILOCK PERIARTICULAR PLATING SYSTEM

Applicant Ebi, L.P.

K number K061098

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HRS 2006-05-19

AXSOS PLUS LOCKING PLATE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K061012

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HRS 2006-05-17

LAPIDUS PLATE

Applicant New Deal, S.A.

K number K060476

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HRS 2006-05-17

TTC PLATE

Applicant New Deal, S.A.

K number K060473

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HRS 2006-05-12

POLYAX LOCKED PLATING SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K060969

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HRS 2006-04-12

STRYKER PLATING SYSTEM

Applicant Howmedica Osteonics Corp.

K number K060798

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HRS 2006-03-22

DIAPHYSEAL PLATE

Applicant Hand Innovations, LLC

K number K060294

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HRS 2006-03-20

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM

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

K number K060156

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HRS 2006-03-17

STRYKER PLATING SYSTEM

Applicant Howmedica Osteonics Corp.

K number K060514

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HRS 2006-02-27

DRLOCK DISTAL RADIUS VOLAR SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K053182

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HRS 2006-02-07

TRIMED BONE PLATES

Applicant TriMed, Inc.

K number K060041

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HRS 2005-12-22

NEXA BONE PLATE AND SCREW SYSTEM

Applicant Nexa Orthopedics, Inc.

K number K053408

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HRS 2005-12-12

ARTHREX TENSIONLOK

Applicant Arthrex, Inc.

K number K052901

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HRS 2005-12-05

SYNTHES (USA) STERNAL FIXATION SYSTEM

Applicant Synthes (Usa)

K number K052683

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HRS 2005-11-16

INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

Applicant Inion , Ltd.

K number K052624

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HRS 2005-10-25

COLLAGEN BONE HEALING PROTECTIVE SHEET

Applicant Collagen Matrix, Inc.

K number K052041

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HRS 2005-10-21

SHOULDER NAIL PLATE

Applicant Hand Innovations, LLC

K number K052294

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HRS 2005-10-17

OLECRANONPLATE WITH ANGULAR STABILITY

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

K number K052368

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HRS 2005-10-12

SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)

Applicant Synthes (Usa)

K number K052677

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HRS 2005-10-07

S-BONE HIP TOOL

Applicant Orthopedic Sciences, Inc.

K number K052538

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HRS 2005-10-07

SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION

Applicant Synthes (Usa)

K number K052390

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HRS 2005-09-28

LOW PROFILE PLATE AND SCREW SYSTEM

Applicant Arthrex, Inc.

K number K052614

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HRS 2005-09-14

DORSAL NAIL PLATE, ANATOMICAL

Applicant Hand Innovations, LLC

K number K052248

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HRS 2005-09-13

B-BOP PLATE

Applicant New Deal, S.A.

K number K052152

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HRS 2005-09-08

VOLAR PLATE SYSTEM

Applicant Dvo Extremity Solutions, LLC

K number K052150

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HRS 2005-09-08

SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES

Applicant Synthes (Usa)

K number K051986

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HRS 2005-09-06

MIOT PLATING SYSTEM

Applicant Orthofix Srl

K number K051945

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HRS 2005-09-06

SBI WRISTFIT

Applicant Small Bone Innovations, LLC

K number K051747

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HRS 2005-08-23

APTUS TITANIUM OSTEOSYNTHESIS SYSTEM

Applicant Medartis, Inc.

K number K051567

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HRS 2005-08-10

PILONPLATE WITH ANGULAR STABILITY

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

K number K052011

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HRS 2005-08-10

CHARLOTTE COMPRESSION PLATE

Applicant Wrightmedicaltechnologyinc

K number K051908

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HRS 2005-08-08

MONDEAL CONTOUR HO SYSTEM

Applicant Kapp Surgical Instrument, Inc.

K number K050657

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