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 2001-03-20

LACTOSORB 5.0 MM WASHER

Applicant Biomet, Inc.

K number K001581

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HWC 2001-03-09

ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM

Applicant Arthrex, Inc.

K number K003816

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HWC 2001-03-07

SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW

Applicant Smith & Nephew, Inc.

K number K002274

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HWC 2001-02-20

SYNTHES HAMSTRING LOOP

Applicant Synthes (Usa)

K number K003700

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HWC 2001-02-15

SMITH & NEPHEW SUTURE ANCHOR

Applicant Smith & Nephew, Inc.

K number K003599

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HWC 2001-02-08

BIOLOK SCREW, BIOSTEON SCREW

Applicant Biocomposites, Ltd.

K number K003641

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HWC 2000-09-22

HOWMEDICA OSTEONICS SHOULDER SCREW

Applicant Howmedica Osteonics Corp.

K number K002654

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HWC 2000-08-25

2.4MM CORTEX SCREW, SELF-TAPPING

Applicant Synthes (Usa)

K number K002271

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HWC 2000-08-25

BIOLOK SCREW

Applicant Biocomposites, Ltd.

K number K002070

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HWC 2000-08-04

STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

Applicant Stryker Endoscopy

K number K993166

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HWC 2000-07-11

THE KALIX IMPLANT

Applicant New Deal, S.A.

K number K001231

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HWC 2000-04-26

BIOLOK SCREW

Applicant Encore Orthopedics, Inc.

K number K993630

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HWC 2000-04-03

ASNIS III CANNULATED SCREW SYSTEM

Applicant Howmedica Osteonics Corp.

K number K000080

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HWC 2000-03-10

NONLINEAR TAPER LAG SCREW

Applicant Theken Surgical

K number K994382

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HWC 2000-03-06

THE LIGAMENT ANCHOR SOFT SCREW

Applicant Corin USA

K number K994152

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HWC 2000-02-25

ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM

Applicant Smith & Nephew, Inc.

K number K994202

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HWC 2000-02-04

I.CO.S SCREW

Applicant New Deal, S.A.

K number K993762

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HWC 2000-02-03

SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

Applicant Synthes (Usa)

K number K000089

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HWC 2000-01-12

BIORCI SCREW

Applicant Smith & Nephew Endoscopy, Inc.

K number K992396

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HWC 1999-12-20

ABSOLUTE ABSORBABLE INTERFERENCE SCREW

Applicant Innovasive Devices, Inc.

K number K993975

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HWC 1999-12-20

EIS THREADED SCREW FRACTURE FIXATION

Applicant Groupe Lepine

K number K991964

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HWC 1999-11-18

RCI FIXATION SCREWS (WITH ASSORTED SIZES)

Applicant Smith & Nephew, Inc.

K number K992945

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HWC 1999-11-16

BONE BULLET SUTURE ANCHOR

Applicant Linvatec Corp.

K number K991024

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HWC 1999-10-08

MODIFICATION TO BONE MULCH SCREW SYSTEM

Applicant Biomet, Inc.

K number K993025

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HWC 1999-09-23

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS

Applicant Electro-Biology, Inc.

K number K992367

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HWC 1999-09-22

MITEK ROTATOR CUFF QUICKANCHOR PLUS

Applicant Mitek Products

K number K992611

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HWC 1999-09-21

CANNULATED SMARTSCREW MODELS 224540C, 224570C

Applicant Bionx Implants, Ltd.

K number K992947

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HWC 1999-09-21

MITEK MINI QUICKANCHOR PLUS

Applicant Mitek Products

K number K992487

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HWC 1999-09-17

MODUS SYSTEM SELF-DRILLING SCREWS

Applicant Medartis AG

K number K992106

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HWC 1999-09-17

BIOBUTTON

Applicant Linvatec Corp.

K number K990194

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HWC 1999-09-01

REUNITE SCREWS

Applicant Biomet Manufacturing, Inc.

K number K992301

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HWC 1999-07-30

STAPLETAC BONE ANCHOR SYSTEM

Applicant Influence, Inc.

K number K992277

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HWC 1999-07-30

BIORC ANCHOR

Applicant Linvatec Corp.

K number K990770

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HWC 1999-07-14

SPIN SNAP-OFF SCREW

Applicant New Deal, S.A.

K number K991477

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HWC 1999-07-01

BIO-INTERFERENCE SCREW

Applicant Innovasive Devices, Inc.

K number K990454

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HWC 1999-06-01

BONE SCREWS

Applicant Bregma International Trading Company , Ltd.

K number K990351

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HWC 1999-05-14

BONE MULCH SCREW SYSTEM

Applicant Biomet, Inc.

K number K991298

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HWC 1999-04-29

STAYFUSE

Applicant Pioneer Surgical Technology

K number K990804

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HWC 1999-04-29

AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM

Applicant Aap Implantate AG

K number K990776

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HWC 1999-04-29

BOLD SCREW

Applicant New Deal, S.A.

K number K990622

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HWC 1999-04-26

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24

Applicant Vilex, Inc.

K number K991197

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HWC 1999-04-26

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW

Applicant Vilex, Inc.

K number K991151

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HWC 1999-03-17

ULTIMAX CORTICAL BONE SCREWS

Applicant Biodynamic Technologies, Inc.

K number K990513

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HWC 1999-03-15

DRG MEDIUM SCREW SYSTEM

Applicant Dolphin Medical Technologies, Inc.

K number K990019

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HWC 1999-02-03

STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED

Applicant Biomet, Inc.

K number K984209

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HWC 1999-01-28

BIOABSORBABLE INTERFERENCE SCREWS

Applicant Smith & Nephew, Inc.

K number K984320

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HWC 1999-01-28

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS

Applicant Sulzer Orthopedics, Inc.

K number K983592

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HWC 1999-01-20

ODI ULTIMATE COMPRESSION HIP SCREW

Applicant Orthopedic Designs, Inc.

K number K984331

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HWC 1998-12-22

PHUSIS ABSORBABLE INTERFERENCE SCREW

Applicant Tornier

K number K970829

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HWC 1998-12-16

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420

Applicant Syntec Scientific Corp.

K number K983495

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HWC 1998-12-07

OSTEO COMPRESSION CONDYLE SCREW SYSTEM

Applicant Osteonics Corp.

K number K983508

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HWC 1998-12-03

OSTEO 4.0MM CANNULATED SCREW SYSTEM

Applicant Osteonics Corp.

K number K983165

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HWC 1998-11-23

OSTEO 5.0MM CANNULATED SCREW SYSTEM

Applicant Stryker Osteonics

K number K983006

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HWC 1998-10-28

DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

Applicant DePuy Orthopaedics, Inc.

K number K982662

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HWC 1998-10-16

ARTHROTEK INTERFERENCE SCREW

Applicant Biomet, Inc.

K number K982497

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HWC 1998-09-08

ENDO ABSORBABLE INTERFERENCE SCREW

Applicant Endo Surgical Concepts, Inc.

K number K980457

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HWC 1998-07-29

SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM

Applicant Synthes (Usa)

K number K982222

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HWC 1998-07-01

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001

Applicant Arthrex, Inc.

K number K981187

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HWC 1998-06-25

CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM

Applicant Buckman Co., Inc.

K number K961320

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HWC 1998-06-22

DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

Applicant Depuy, Inc.

K number K981670

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HWC 1998-05-20

RCI FIXATION SCREWS

Applicant Smith & Nephew, Inc.

K number K980841

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HWC 1998-05-11

SYNTHES 3.0 MM PC-FIX SYSTEM

Applicant Synthes (Usa)

K number K981372

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HWC 1998-05-11

OSTEO 4.0MM CANNULATED SCREW SYSTEM

Applicant Osteonics Corp.

K number K981259

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HWC 1998-04-29

INNOVASIVE DEVICES MENISCAL SCREW

Applicant Innovasive Devices, Inc.

K number K980681

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HWC 1998-04-29

HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS

Applicant Howmedica Corp.

K number K980364

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HWC 1998-04-03

DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW

Applicant Depuy, Inc.

K number K980440

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HWC 1998-03-27

BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW

Applicant Bionx Implants, Inc.

K number K972919

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HWC 1998-03-18

AUTO-DRIVE BONE SCREW

Applicant Osteomed Corp.

K number K974785

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HWC 1998-03-12

BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS

Applicant Biodynamic Technologies, Inc.

K number K974756

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HWC 1998-03-03

MENISCAL REPAIR DEVICE

Applicant Linvatec Corp.

K number K974538

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HWC 1998-02-27

BIOSCREW ABSORBABLE INTERFERENCE SREW

Applicant Linvatec Corp.

K number K973758

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HWC 1998-01-23

ULTIMATE COMPRESSION SCREW SYSTEM

Applicant Orthopedic Designs, Inc.

K number K972722

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HWC 1998-01-16

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW

Applicant Vilex, Inc.

K number K973309

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HWC 1998-01-05

DRG LARGE SCREW SYSTEM

Applicant Dolphin Medical Technologies, Inc.

K number K973810

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HWC 1997-11-20

ORTHOPEDIC SCREW SYSTEM

Applicant Ferguson Medical

K number K972217

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HWC 1997-11-10

THE CORIFIX LIGAMENT ANCHOR

Applicant Corin USA

K number K973005

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HWC 1997-11-07

SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II

Applicant Spinal Concepts, Inc.

K number K973586

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HWC 1997-10-01

DEPUY DUPONT ABSORBABLE SET SCREW

Applicant Depuy, Inc.

K number K972494

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HWC 1997-10-01

LEIBINGER SELF-DRILLING SCREW

Applicant Howmedica Leibinger, Inc.

K number K970912

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HWC 1997-09-19

ACUFEX SCREW CANNULA

Applicant Smith & Nephew Endoscopy, Inc.

K number K972599

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HWC 1997-08-29

BTI CORTICAL BONE SCREWS

Applicant Biodynamic Technologies, Inc.

K number K972403

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HWC 1997-08-05

STRYKER WEDGE INTERFERENCE SCREW SYSTEM

Applicant Stryker Endoscopy

K number K972233

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HWC 1997-07-30

OSTEO CANNULATED SCREW SYSTEM

Applicant Osteonics Corp.

K number K971800

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HWC 1997-07-09

OSTEO COMPRESSION HIP SCREW SYSTEM

Applicant Osteonics Corp.

K number K971654

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HWC 1997-07-09

SCARF THREAD-HEAD (TM) HEAD SCREW

Applicant Landos, Inc.

K number K971070

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HWC 1997-07-09

TWIST-OFF (TM) SCREW

Applicant Landos, Inc.

K number K971069

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HWC 1997-07-09

34MM SCARF THREAD-HEAD(TM) SCREW

Applicant Landos, Inc.

K number K971068

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HWC 1997-06-27

OSTEO SMALL AND MINI BONE SCREWS

Applicant Osteonics Corp.

K number K971778

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HWC 1997-06-09

DEPUY LOW PROFILE BONE SCREW

Applicant Depuy, Inc.

K number K970929

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HWC 1997-04-30

TITANIUM ALLOY BONE SCREWS

Applicant Aesculap, Inc.

K number K970549

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HWC 1997-04-03

BIOMET BONE SCREW

Applicant Biomet, Inc.

K number K964970

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HWC 1997-02-27

9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW

Applicant Smith & Nephew, Inc.

K number K965073

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HWC 1997-01-22

NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW

Applicant Northwest Precision Technologies

K number K963937

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HWC 1997-01-22

LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS

Applicant Howmedica Leibinger, Inc.

K number K963739

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HWC 1996-11-18

HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)

Applicant Depuy, Inc.

K number K955733

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HWC 1996-11-14

DEPUY MOTECH PEAK FIXATION SYSTEM

Applicant Depuy, Inc.

K number K963350

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HWC 1996-11-14

BIOSCREW ABSORBABLE INTERFERENCE SCREW

Applicant Linvatec Corp.

K number K960652

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HWC 1996-11-13

EZ-FIX CANNULATED SCREW SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K962706

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HWC 1996-11-08

SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS

Applicant Synthes (Usa)

K number K963192

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HWC 1996-11-08

SYNTHES STERILE 4.5 MM CANNULATED SCREWS

Applicant Synthes (Usa)

K number K963172

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