Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA product code KTT · 378 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: 1979-04-10 – 2026-06-11

KTT 2011-11-02

DYNA-EXTOR II

Applicant Bk Meditech, Co., Ltd.

K number K110426

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KTT 2011-10-24

FRAMEWALKER

Applicant Quantum Medical Concepts, LLC

K number K111993

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KTT 2011-10-20

XTRAFIX EXTERNAL FIXATION SYSTEM

Applicant Extraortho, Inc.

K number K111155

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KTT 2011-08-03

CONSTRUX EXTERNAL FIXATION DEVICE

Applicant Ebi, LLC

K number K111376

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KTT 2011-05-11

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM

Applicant Renovis Surgical Technologies, LLC

K number K110965

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KTT 2011-05-03

MAC MALE ADAPTER

Applicant Biomet Trauma (Aka Ebi, LLC)

K number K102843

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KTT 2011-04-13

ODRC-DYNAMIC HIP SCREW SYSTEM

Applicant Orthopaedic Device Research Center

K number K103015

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KTT 2011-03-14

NEWFIX EXTERNAL FIXATION SYSTEM

Applicant Technologia Y Diseno Industrial, S.A DE C.V

K number K101338

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KTT 2011-02-08

SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE

Applicant Smith & Nephew, Inc.

K number K110069

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KTT 2010-12-21

TARGON FN SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K102057

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KTT 2010-12-03

MERETE LOCKING BONE PLATE SYSTEM II

Applicant Merete Medical GmbH

K number K102688

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KTT 2010-10-22

QUANTUM RING FIXATION SYSTEM MODEL ISF

Applicant Quantum Medical Concepts, LLC

K number K101759

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KTT 2010-09-27

SMITH & NEPHEW CIRCULAR FIXATION SYSTEM

Applicant Smith & Nephew, Inc.

K number K093047

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KTT 2010-09-17

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM

Applicant Acute Innovations, LLC

K number K101170

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KTT 2010-09-02

JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING

Applicant Smith & Nephew, Inc.

K number K100795

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KTT 2010-08-26

MDPO FRAME SYSTEM

Applicant Mdpo, LLC

K number K093753

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KTT 2010-06-10

SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES

Applicant Wrightmedicaltechnologyinc

K number K100137

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KTT 2010-05-27

FUSION MEDICAL RING LOCK SYSTEM

Applicant John J Riccio

K number K100857

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KTT 2010-05-11

SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

Applicant Synthes (Usa)

K number K092190

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KTT 2010-03-03

SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL

Applicant Synthes (Usa)

K number K090658

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KTT 2010-01-07

MINI RAIL EXTERNAL FIXATOR SYSTEM

Applicant Small Bone Innovations, Inc.

K number K093550

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KTT 2009-12-10

AFGHAN EXTERNAL FIXATOR

Applicant Smith & Nephew, Inc.

K number K092002

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KTT 2009-12-01

BIOMET VISION FOOTRING SYSTEM

Applicant Ebi, L.P.

K number K093057

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KTT 2009-10-08

HOFFMAN XPRESS LINE EXTENSION

Applicant Howmedica Osteonics Corp.

K number K092834

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KTT 2009-09-08

ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)

Applicant Anglefix

K number K091619

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KTT 2009-08-26

SIGN HIP CONSTRUCT (SHC), MODEL: 701

Applicant Surgical Implant Generation Network (Sign)

K number K083582

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KTT 2009-07-24

EXTRAFIX EXTERNAL FIXATION SYSTEM

Applicant Qfx Technologies, Inc.

K number K091258

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KTT 2009-06-08

SMITH & NEPHEW RAIL SYSTEM

Applicant Smith & Nephew, Inc.

K number K090926

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KTT 2009-04-22

MERETE LOCKING BONE PLATE SYSTEM

Applicant Merete Medical, Inc.

K number K090063

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KTT 2009-03-23

ACE FISCHER EXTERNAL FIXATION SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K083789

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KTT 2009-03-02

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Sterilmed, Inc.

K number K083636

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KTT 2009-02-05

NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

Applicant Nutek Orthopaedics, Inc.

K number K082833

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KTT 2008-11-18

SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL

Applicant Synthes (Usa)

K number K082650

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KTT 2008-08-18

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Sterilmed, Inc.

K number K081586

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KTT 2008-08-13

REPROCESSED EXTERNAL FIXATION ACCESSORIES

Applicant Sterilmed, Inc.

K number K081342

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KTT 2008-07-30

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS

Applicant Biomet Trauma

K number K081244

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KTT 2008-07-18

VARIAX DISTAL FIBULA PLATE

Applicant Howmedica Osteonics Corp.

K number K081284

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KTT 2008-05-29

OMEGA 3 TROCHANTERIC STABILIZING PLATE

Applicant Howmedica Osteonics Corp.

K number K081278

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KTT 2008-04-25

EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD

Applicant Advanced Orthopaedic Solutions, Inc.

K number K080408

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KTT 2008-03-07

JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE

Applicant Smith & Nephew, Inc.

K number K072212

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KTT 2008-02-15

HOFFMANN LIGHT SYSTEM

Applicant Howmedica Osteonics Corp.

K number K073076

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KTT 2008-02-14

VARIAX ELBOW SYSTEM

Applicant Howmedica Osteonics Corp.

K number K073527

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KTT 2008-02-07

SIDEKICK RAIL FIXATOR

Applicant Wrightmedicaltechnologyinc

K number K080071

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KTT 2007-11-09

SUPERCABLE GRIP AND PLATE SYSTEM

Applicant Kinamed, Inc.

K number K072250

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KTT 2007-08-29

AAP APS SYSTEM

Applicant Aap Implantate AG

K number K071852

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KTT 2007-07-09

BIOMET VISION FOOTRING SYSTEM

Applicant Biomet Manufacturing Corp

K number K071395

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KTT 2007-06-29

MODIFICATION TO:SBI RINGFIX

Applicant Small Bone Innovations, Inc.

K number K071394

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KTT 2007-05-16

IOS EXTERNAL FIXATOR, MODEL 2-0-0

Applicant Intelligent Orthopaedics, Ltd.

K number K070724

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KTT 2007-04-12

OMEGA 3 SUPRACONDYLAR PLATE

Applicant Howmedica Osteonics Corp.

K number K070454

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KTT 2007-04-02

BLUE SHARK

Applicant Meridan Medical

K number K070016

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KTT 2007-01-22

MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE

Applicant Merete Medical GmbH

K number K063487

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KTT 2007-01-04

DEPUY PEAK FX HIP PLATE

Applicant DePuy Orthopaedics, Inc.

K number K063509

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KTT 2006-12-22

AEQUALIS HUMERAL PLATE

Applicant Tornier

K number K063551

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KTT 2006-09-05

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Ascent Healthcare Solutions

K number K061759

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KTT 2006-08-15

OMEGA 3 SYSTEM

Applicant Howmedica Osteonics Corp.

K number K062066

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KTT 2006-07-17

FRAGMENT PLATE SYSTEM

Applicant Hand Innovations, LLC

K number K061748

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KTT 2006-04-21

VARIAX LOCKING PLATE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K060613

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KTT 2006-04-21

UNITY HUMERAL PLATE

Applicant Tornier

K number K060545

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KTT 2006-01-27

REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K052918

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KTT 2006-01-11

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K053472

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KTT 2005-12-22

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Vanguard Medical Concepts, Inc.

K number K053051

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KTT 2005-12-09

HOFFMANN II ROD TO WIRE COUPLING

Applicant Howmedica Osteonics Corp.

K number K053349

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KTT 2005-11-22

HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K053038

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KTT 2005-11-22

VILEX X-FIX

Applicant Vilex, Inc.

K number K052196

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KTT 2005-11-10

EXTERNAL FIXATION

Applicant Gexfix USA, Inc.

K number K052605

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KTT 2005-10-17

FRAGMENT SPECIFIC FIXATOR

Applicant David J. Slutsky MD

K number K052498

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KTT 2005-09-21

EBI DYNAFIX VISION FOOTPLATE SYSTEM

Applicant Ebi, L.P.

K number K052239

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KTT 2005-09-21

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Sterilemed, Inc.

K number K051957

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KTT 2005-09-06

R&R EXTERNAL FIXATION SYSTEM

Applicant R&R Medical, Inc.

K number K052005

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KTT 2005-09-06

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Vanguard Medical Concepts, Inc.

K number K051616

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KTT 2005-08-25

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K052064

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KTT 2005-08-25

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K052062

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KTT 2005-08-22

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K052065

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KTT 2005-08-05

MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K052037

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KTT 2005-07-27

SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM

Applicant Synthes (Usa)

K number K051600

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KTT 2005-07-22

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Vanguard Medical Concepts, Inc.

K number K051180

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KTT 2005-07-19

GENEROS SB SMALL BONE DISTRACTION IMPLANT

Applicant Orthonetx, Inc.

K number K051162

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KTT 2005-07-13

SYNTHES (USA) LOW-PROFILE WRIST FIXATOR

Applicant Synthes (Usa)

K number K051049

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KTT 2005-06-29

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K051554

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KTT 2005-06-29

R-X-FIX EXTERNAL FIXATOR

Applicant R-X-Fix

K number K051017

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KTT 2005-05-04

HA COATED LAG SCREW

Applicant Smith & Nephew, Inc.

K number K050849

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KTT 2005-03-14

MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM

Applicant Merete Medical GmbH

K number K050457

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KTT 2005-03-04

HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K050048

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KTT 2005-02-11

E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT

Applicant Signal Medical Corp.

K number K043289

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KTT 2005-02-07

STEALTH FUSION SYSTEM, MODEL RR 1000

Applicant R&R Medical, Inc.

K number K043174

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KTT 2005-01-21

TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE

Applicant DePuy Orthopaedics, Inc.

K number K043113

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KTT 2005-01-18

SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE

Applicant Synthes (Usa)

K number K043039

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KTT 2005-01-07

5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN

Applicant Peter Stevens, MD

K number K033856

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KTT 2004-11-17

WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES

Applicant Zimmer, Inc.

K number K042761

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KTT 2004-11-16

SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES

Applicant Synthes (Usa)

K number K042895

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KTT 2004-10-07

IIIZAROV PULLEY SYSTEM

Applicant Smith & Nephew, Inc.

K number K042436

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KTT 2004-10-07

LOCON VLS DISTAL RADIUS PLATE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K042358

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KTT 2004-09-24

JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE

Applicant Smith & Nephew, Inc.

K number K042312

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KTT 2004-09-24

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K042019

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KTT 2004-09-08

SYNTHES (USA) LCP CURVED PLATES

Applicant Synthes (Usa)

K number K041911

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KTT 2004-09-08

NUMELOCK II SYSTEM

Applicant Howmedica Osteonics Corp.

K number K041709

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KTT 2004-09-08

HOFFMANN II FOOT RING

Applicant Howmedica Osteonics Corp.

K number K041706

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KTT 2004-07-06

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K040935

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KTT 2004-07-01

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES

Applicant Hand Innovations, Inc.

K number K041081

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KTT 2004-07-01

OMEGA 2 SYSTEM

Applicant Howmedica Osteonics Corp.

K number K041001

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