Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Screw, Fixation, Bone

FDA product code HWC · 996 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3040
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-01-14 – 2026-09-25

HWC 2006-04-06

HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

Applicant Conmed Linvatec

K number K060714

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HWC 2006-04-03

ARTHREX ARTHOERESIS IMPLANT

Applicant Arthrex, Inc.

K number K053543

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HWC 2006-03-13

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

Applicant Inion , Ltd.

K number K060393

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HWC 2006-03-07

CSS CANNULATED SCREW SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K060428

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HWC 2006-02-23

STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.

Applicant Regeneration Technologies, Inc.

K number K060253

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HWC 2006-02-23

BIO-MINI REVO SUTURE ANCHOR

Applicant Conmed Linvatec

K number K053561

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HWC 2006-02-23

BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR

Applicant Smith & Nephew, Inc.

K number K053344

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HWC 2006-01-26

NEXA COMPRESSION SCREW

Applicant Nexa Orthopedics, Inc.

K number K060071

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HWC 2006-01-26

KOBY SURGICAL INTERNAL FIXATION SYSTEM

Applicant Koby Surgical

K number K060026

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HWC 2006-01-26

ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS

Applicant Arthrex, Inc.

K number K053338

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HWC 2006-01-05

5TH METATARSAL FRACTURE SCREW

Applicant Wrightmedicaltechnologyinc

K number K053136

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HWC 2005-12-14

NEXA BONE SCREW SYSTEM

Applicant Nexa Orthopedics, Inc.

K number K053394

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HWC 2005-12-07

KALIX II IMPLANT, MODEL 141 0XX WITH XX

Applicant New Deal, S.A.

K number K053093

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HWC 2005-11-16

STERLING INTERFERENC SCREW HT

Applicant Regeneration Technologies, Inc.

K number K052405

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HWC 2005-11-07

ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS

Applicant Arthrex, Inc.

K number K052607

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HWC 2005-11-07

SBI AUTOFIX

Applicant Small Bone Innovations, LLC

K number K052576

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HWC 2005-11-04

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60

Applicant Sciences For Bio Materials

K number K050407

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HWC 2005-10-17

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K052630

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HWC 2005-09-27

ARTHREX TENODESIS FAMILY

Applicant Arthrex, Inc.

K number K051726

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HWC 2005-09-07

REFIX INTERNAL FRACTURE FIXATION SCREWS

Applicant Xtremi-T, LLC

K number K050388

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HWC 2005-09-06

MBARESORB IMPLANT

Applicant Kinetikos Medical, Inc.

K number K051611

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HWC 2005-08-31

TRIABSORB COMPOSITE SCREW

Applicant Advanced Biomaterials

K number K050468

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HWC 2005-08-25

MATRYX INTERFERENCE SCREW

Applicant Linvatec Biomaterials, Inc.

K number K052080

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HWC 2005-07-26

PLC SCREW

Applicant Smith & Nephew, Inc.

K number K051310

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HWC 2005-07-11

ROI FUSION RODS & PLATES

Applicant Reiley Orthopaedics, Inc.

K number K051309

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HWC 2005-07-07

MERETE TWISTCUT SNAP-OFF BONE SCREW

Applicant Merete Medical GmbH

K number K051323

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HWC 2005-07-07

PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES

Applicant Zimmer, Inc.

K number K051098

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HWC 2005-06-17

ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM

Applicant Arc Surgical, LLC

K number K043176

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HWC 2005-06-09

STERLING INTERFERENCE SCREW ST

Applicant Regeneration Technologies, Inc.

K number K050767

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HWC 2005-05-27

MERETE DUOTHREADTM BONE SCREW

Applicant Merete Medical GmbH

K number K050924

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HWC 2005-05-18

PRECIMED CANNULATED SCREW SYSTEM

Applicant Precimed, Inc.

K number K050754

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HWC 2005-05-12

ARTHREX TAK FAMILY

Applicant Arthrex, Inc.

K number K050749

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HWC 2005-04-27

SYNTHES (USA) 3.5MM CONICAL SCREWS

Applicant Synthes (Usa)

K number K050683

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HWC 2005-04-21

SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS

Applicant Synthes (Usa)

K number K050636

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HWC 2005-04-15

ARTHERX CORKSCREW FT II SUTURE ANCHOR

Applicant Arthrex, Inc.

K number K050358

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HWC 2005-04-11

CHARLOTTE SNAP-OFF SCREW

Applicant Wrightmedicaltechnologyinc

K number K050819

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HWC 2005-03-25

BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET

Applicant Linvatec Corp.

K number K050497

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HWC 2005-03-21

MODIFICATION TO: ARTHREX V-TAK

Applicant Arthrex, Inc.

K number K050634

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HWC 2005-03-17

STABILIZATION SCREW

Applicant New Deal, S.A.

K number K050346

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HWC 2005-02-24

EPIPHYSIS SCREW

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

K number K043410

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HWC 2005-02-18

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

Applicant Inion , Ltd.

K number K043142

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HWC 2005-02-11

ASIAN INTRAMEDULLARY HIP SCREW NAILS

Applicant Smith & Nephew, Inc.

K number K050226

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HWC 2005-02-03

SYNTHES 3.5MM CORTEX SCREWS

Applicant Synthes (Usa)

K number K043185

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HWC 2005-01-26

CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003

Applicant Wrightmedicaltechnologyinc

K number K043583

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HWC 2005-01-21

MULTI-USE COMPRESSION SCREW

Applicant Wrightmedicaltechnologyinc

K number K043102

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HWC 2005-01-19

CHARLOTTE HIGH-DEMAND COMPRESSION SCREW

Applicant Wrightmedicaltechnologyinc

K number K043281

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HWC 2004-12-20

OSS/(SCARF)- AND OSW-SCREW

Applicant O.M.T. Oberflachen-Und Materialtechnologie GmbH

K number K042079

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HWC 2004-12-14

ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR

Applicant Arthrex, Inc.

K number K043337

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HWC 2004-12-14

OPUS MINIMAGNUM ANCHOR WITH INSERTER

Applicant Opus Medical, Inc.

K number K042584

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HWC 2004-12-14

BIO-CORE INTERFERENCE SCREW

Applicant Biomet, Inc.

K number K042552

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HWC 2004-12-14

PLLA CANNULATED INTERFERENCE SCREW

Applicant Advanced Biomaterials

K number K032830

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HWC 2004-11-09

FASTIN RC ANCHOR

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K041075

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HWC 2004-11-09

SPIRALOK ANCHOR

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K041069

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HWC 2004-11-05

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE

Applicant Coapt Systems, Inc.

K number K042796

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HWC 2004-11-04

BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE

Applicant Linvatec Corp.

K number K042778

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HWC 2004-11-04

ARTHREX TENODESIS SCREW FAMILY

Applicant Arthrex, Inc.

K number K041356

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HWC 2004-11-04

ARTHREX TRIMIT FAMILY

Applicant Arthrex, Inc.

K number K041189

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HWC 2004-10-20

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

Applicant Scandius Biomedical, Inc.

K number K041961

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HWC 2004-10-07

SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS

Applicant Synthes (Usa)

K number K042356

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HWC 2004-09-28

ENDOTINE MIDFACE B 4.5 DEVICE

Applicant Coapt Systems, Inc.

K number K041835

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HWC 2004-09-16

ORTHO-PRO CANNULATED BONE SCREWS

Applicant Ortho-Pro, LLC

K number K042310

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HWC 2004-09-16

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

Applicant Linvatec Biomaterials, Ltd.

K number K042295

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HWC 2004-09-16

BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE

Applicant Triage Medical, Inc.

K number K042244

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HWC 2004-09-16

HYPROCURE SUBTALAR IMPLANT SYSTEM

Applicant Graham Medical Technologies, LLC

K number K042030

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HWC 2004-09-08

BIOPRO SUBTALAR IMPLANT

Applicant Biopro, Inc.

K number K041936

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HWC 2004-09-08

SCANDIUS ACL RECONSTRUCTION SYSTEM

Applicant Scandius Biomedical, Inc.

K number K041749

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HWC 2004-09-01

SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS

Applicant Synthes (Usa)

K number K041533

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HWC 2004-08-27

ENDOTINE FOREHEAD TRIPLE DEVICE

Applicant Coapt Systems, Inc.

K number K042078

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HWC 2004-08-25

SNAP-OFF SCREWS

Applicant Fournitures Hospitalieres Industrie

K number K041456

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HWC 2004-08-19

SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW

Applicant Smith & Nephew, Inc.

K number K040542

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HWC 2004-08-16

INION TRINION BIODEGRADABLE MENISCUS SCREW

Applicant Inion , Ltd.

K number K031714

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HWC 2004-08-05

TALUS OF VILEX (TOV)

Applicant Vilex, Inc.

K number K041289

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HWC 2004-08-05

VILEX BONE PLATE SYSTEM

Applicant Vilex, Inc.

K number K041287

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HWC 2004-07-28

RESORBABLE INTERFERENCE SCREW

Applicant Arthrotek, Inc.

K number K041274

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HWC 2004-06-30

LACTOSCREW SCREW ANCHOR

Applicant Biomet Orthopedics, Inc.

K number K033355

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HWC 2004-06-24

BIO-EUROLIG INTERFERENCE SCREW

Applicant Fournitures Hospitalieres Industrie

K number K031939

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HWC 2004-06-15

SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS

Applicant Synthes (Usa)

K number K040701

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HWC 2004-05-28

LITTLE GRAFTER SCREW

Applicant Biocomposites, Ltd.

K number K040265

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HWC 2004-05-25

MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW

Applicant Smith & Nephew, Inc.

K number K040656

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HWC 2004-05-21

MICROMAX SUTURE ANCHOR

Applicant Biomet, Inc.

K number K040475

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HWC 2004-05-10

ENDOTINE TRANSBLEPH DEVICE

Applicant Coapt Systems, Inc.

K number K040740

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HWC 2004-05-07

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

Applicant Linvatec Biomaterials, Inc.

K number K032894

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HWC 2004-04-16

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED

Applicant Linvatec Biomaterials, Ltd.

K number K032447

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HWC 2004-04-14

SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS

Applicant Smith & Nephew, Inc.

K number K040331

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HWC 2004-03-31

HERCULON SOFT TISSUE REATTACHMENT SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K040594

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HWC 2004-03-31

BIOCRYL RAPIDE INTERFERENCE SCREW

Applicant Mitek Worldwide

K number K032717

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HWC 2004-03-01

KOMPRESSOR SCREW SYSTEM

Applicant Kinetikos Medical, Inc.

K number K040356

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HWC 2004-03-01

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS

Applicant Synthes (Usa)

K number K033975

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HWC 2004-03-01

BILOK ST SCREW

Applicant Biocomposites, Ltd.

K number K033792

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HWC 2004-02-23

TITANIUM CANNULATED INTERFERENCE SCREW

Applicant Advanced Biomaterials

K number K033749

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HWC 2004-01-15

ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

Applicant Acumed, LLC

K number K033639

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HWC 2004-01-13

THE ANSWER SCREW SUPPLEMENTATION SYSTEM

Applicant Simplicity Orthopedic Solutions, LLC

K number K032966

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HWC 2003-12-31

BIOANCHOR WITH DISPOSABLE DRIVER

Applicant Linvatec Corp.

K number K033804

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HWC 2003-12-18

COAPT ENDOTINE CHIN 3.5 DEVICE

Applicant Coapt Systems, Inc.

K number K033524

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HWC 2003-12-15

LORENZ STERNAL CLOSURE SYSTEM

Applicant Walter Lorenz Surgical, Inc.

K number K033740

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HWC 2003-12-15

SUBTALAR ARTHRORISIS IMPLANT

Applicant Nexa Orthopedics, Inc.

K number K032902

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HWC 2003-11-13

MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

Applicant Stryker Endoscopy

K number K033252

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HWC 2003-11-05

LACTOSORB TIBIAL L-15 SCREW AND WASHER

Applicant Biomet, Inc.

K number K033233

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HWC 2003-10-22

STS SCREW

Applicant Ortho-Pro, LLC

K number K032682

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HWC 2003-10-15

BIO-INTRAFIX TIBIAL SCREW AND SHEATH

Applicant Mitek Worldwide

K number K032167

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