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 2009-02-05

BIODRIVE CANNULATED SCREW SYSTEM

Applicant Biomet Trauma

K number K082874

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HWC 2008-12-08

MAXTORQUE MINI CANNULATED SCREW SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K082574

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HWC 2008-11-25

ORTHOPEDIATRICS BONE SCREWS

Applicant OrthoPediatrics Corp.

K number K082949

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HWC 2008-11-25

POGO SCREW

Applicant Fxdevices

K number K080649

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HWC 2008-11-07

HEALIX TI ANCHOR

Applicant Depuy Mitek, A Johnson & Johnson Co.

K number K082282

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HWC 2008-11-07

AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45

Applicant Arex USA

K number K081011

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HWC 2008-11-05

DARCO SMALL SCREW

Applicant Wrightmedicaltechnologyinc

K number K082320

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HWC 2008-10-30

UNITY BETA ANCHOR SYSTEM

Applicant Bonutti Research, Inc.

K number K082906

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HWC 2008-10-01

OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500

Applicant Arthrocare Corp.

K number K081893

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HWC 2008-09-17

PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS

Applicant Smith & Nephew, Inc.

K number K082516

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HWC 2008-08-29

EXTREMITY MEDICAL COMPRESSION SCREW

Applicant Extremity Medical, LLC

K number K081934

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HWC 2008-08-20

JMEA CANNULATED BONE SCREW SYSTEM

Applicant Jmea Corporation

K number K080259

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HWC 2008-08-12

BIOACTIF OSTEOTRANS INTERFENCE SCREW

Applicant Takiron Co., Ltd.

K number K081390

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HWC 2008-08-05

BIOPRO GO-EZ SCREW

Applicant Biopro, Inc.

K number K081149

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HWC 2008-08-04

TIGER CANNULATED SCREW SYSTEM

Applicant Trilliant Surgical, Ltd.

K number K081510

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HWC 2008-07-23

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5

Applicant Trauson (Jiangsu) Medical Instrument Co., Ltd.

K number K073159

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HWC 2008-07-18

MERETE 3.0 AND 3.5 MM LOCKING SCREWS

Applicant Merete Medical GmbH

K number K081513

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HWC 2008-07-17

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

Applicant Synthes (Usa)

K number K081700

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HWC 2008-07-14

CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR

Applicant Conmed Linvatec

K number K072291

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HWC 2008-07-10

ENSPLINT TM BONE SCREW

Applicant Sonoma Orthopedic Products, Inc.

K number K080778

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HWC 2008-07-01

TLS FIXATION SYSTEM

Applicant Fournitures Hospitalieres Industrie

K number K080974

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HWC 2008-06-20

MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR

Applicant Biocomposites, Ltd.

K number K081428

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HWC 2008-06-18

BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN

Applicant Bioretec, Ltd.

K number K081392

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HWC 2008-06-11

BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS

Applicant Biomet Manufacturing, Inc.

K number K080088

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HWC 2008-05-13

OSTEOTRANS-OT SCREW

Applicant Takiron Co., Ltd.

K number K073312

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HWC 2008-05-01

SYNTHES 6.5MM MIDFOOT FUSION BOLT

Applicant Synthes (Usa)

K number K081071

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HWC 2008-04-23

SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS

Applicant Synthes (Usa)

K number K080943

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HWC 2008-04-23

PLLA, HA SCREW

Applicant Smith & Nephew Inc., Endoscopy Div.

K number K080358

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HWC 2008-04-10

DARCO HEADLESS COMPRESSION SCREW

Applicant Wrightmedicaltechnologyinc

K number K080850

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HWC 2008-03-25

AAP CANNULATED SCREW AND DARCO HEADED SCREW

Applicant Aap Implantate AG

K number K080101

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HWC 2008-03-14

SUB-TALAR LOK, MODEL 7-11 MM

Applicant Instratek, Inc.

K number K080280

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HWC 2008-03-12

MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K080352

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HWC 2008-03-04

TWINFIX PK FP SUTURE ANCHOR

Applicant Smith & Nephew, Inc.

K number K073509

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HWC 2008-02-19

APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM

Applicant Cayenne Medical, Inc.

K number K073426

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HWC 2007-12-10

TWINFIX FT PK

Applicant Smith & Nephew Inc., Endoscopy Division

K number K072785

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HWC 2007-12-04

MEMOMETAL BONE ANCHORS

Applicant Memometal Technologies

K number K071941

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HWC 2007-11-27

MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER

Applicant Cayenne Medical, Inc.

K number K073054

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HWC 2007-11-02

ACTIVASCREW

Applicant Bioretec, Ltd.

K number K072848

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HWC 2007-09-20

HARPOON SUTURE ANCHOR

Applicant Biomet Sports Medicine, Inc.

K number K071816

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HWC 2007-09-17

STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS

Applicant Stryker Endoscopy

K number K071157

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HWC 2007-09-12

MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C

Applicant KARL STORZ Endoscopy-America, Inc.

K number K071437

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HWC 2007-09-10

SBI TWISTOFIX

Applicant Small Bone Innovations, Inc.

K number K071541

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HWC 2007-08-31

DOMINATOR

Applicant Biocomposites, Ltd.

K number K072127

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HWC 2007-08-29

SBI FOREFOOT SET

Applicant Small Bone Innovations, Inc.

K number K063635

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HWC 2007-08-27

SBI ARTFIX

Applicant Small Bone Innovations, Inc.

K number K071656

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HWC 2007-08-14

GRAFTLOCK SCREW, ST SCREW

Applicant Biocomposites, Ltd.

K number K071952

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HWC 2007-08-13

IFS BONE FIXATION DEVICES

Applicant Internal Fixation Systems, Inc.

K number K071035

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HWC 2007-08-09

HEALIX ANCHOR

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K071481

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HWC 2007-08-09

PEEK KNOTLESS ANCHORS

Applicant Biomet Sports Medicine, Inc.

K number K070389

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HWC 2007-08-03

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

Applicant Inion OY

K number K071464

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HWC 2007-07-31

SUBTALAR IMPLANT

Applicant Biomet Sports Medicine, Inc.

K number K071498

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HWC 2007-07-09

QWIX POSITIONING SCREW

Applicant Newdeal Sas

K number K071639

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HWC 2007-06-29

ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW

Applicant Arthrex, Inc.

K number K071177

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HWC 2007-06-14

CANNULATED SCREW

Applicant Fournitures Hospitalieres Industrie

K number K070617

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HWC 2007-05-17

MODIFICATION TO BILOK ST SCREW

Applicant Biocomposites, Ltd.

K number K071115

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HWC 2007-05-17

MODIFICATION TO BILOK SCREW

Applicant Biocomposites, Ltd.

K number K071091

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HWC 2007-05-11

ASNIS MICRO CANNULATED SCREW

Applicant Howmedica Osteonics Corp.

K number K071092

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HWC 2007-05-11

ALLOFIX PUSH-IN ANCHOR

Applicant Musculoskeletal Transplant Foundation

K number K070347

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HWC 2007-05-09

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937

Applicant Regeneration Technologies, Inc.

K number K063584

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HWC 2007-05-08

METASURG SUBTALAR IMPLANT

Applicant Metasurg

K number K070441

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HWC 2007-05-04

LAGWIRE SYSTEM

Applicant Fxdevices

K number K070393

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HWC 2007-05-01

MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS

Applicant Zimmer, Inc.

K number K070906

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HWC 2007-03-29

CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER

Applicant Wrightmedicaltechnologyinc

K number K070525

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HWC 2007-03-29

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

Applicant Science For Biomaterials

K number K070507

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HWC 2007-03-21

MEMOMETAL FIXOS SCREWS

Applicant Memometal Technologies

K number K070039

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HWC 2007-03-15

UNITY ALPHA SYSTEM

Applicant Bonutti Research, Inc.

K number K062820

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HWC 2007-03-02

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

Applicant Conmed Linvatec Biomaterials

K number K063588

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HWC 2007-03-02

OSTEOMED HEADLESS CANNULATED SCREW SYSTEM

Applicant Osteomed LP

K number K063298

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HWC 2007-01-31

GSO BONE FIXATION FASTENERS

Applicant Gold Standard Orthopaedics, LLC

K number K063589

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HWC 2006-12-27

ARC SURGICAL BONE REDUCTION SCREW

Applicant Arc Surgical, LLC

K number K063244

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HWC 2006-12-15

VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K063478

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HWC 2006-12-14

APERFIX TIBIAL IMPLANT WITH INSERTER

Applicant Cayenne Medical, Inc.

K number K063070

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HWC 2006-12-13

ARTHREX PUSHLOCK

Applicant Arthrex, Inc.

K number K063479

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HWC 2006-11-22

ACTIVASCREW

Applicant Bioretec, Ltd.

K number K062980

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HWC 2006-11-17

APERFIX FEMORAL IMPLANT WITH INSERTER

Applicant Cayenne Medical, Inc.

K number K062487

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HWC 2006-10-31

OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM

Applicant Osteomed LP

K number K062863

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HWC 2006-10-25

DARCO FORCE TITANIUM COMPRESSION SCREW

Applicant Darco International, Inc.

K number K062103

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HWC 2006-10-19

FRS SCREW

Applicant DePuy Orthopaedics, Inc.

K number K062352

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HWC 2006-10-19

ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY

Applicant Arthrex, Inc.

K number K061863

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HWC 2006-10-04

MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM

Applicant Inion , Ltd.

K number K062617

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HWC 2006-09-27

ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES

Applicant Arthrex, Inc.

K number K062679

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HWC 2006-09-25

DOUBLEPLAY SUTURE ANCHOR

Applicant Biocomposites, Ltd.

K number K061949

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HWC 2006-09-19

ARC SURGICAL BIOTRAK SCREW

Applicant Arc Surgical, LLC

K number K061763

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HWC 2006-09-08

TIMESH SELF DRILLING SCREW

Applicant Medtronic Neurosurgery

K number K062348

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HWC 2006-07-27

SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS

Applicant Synthes (Usa)

K number K061621

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HWC 2006-07-26

IFS CANNULATED BONE SCREW

Applicant Internal Fixation Systems, Inc.

K number K061620

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HWC 2006-07-25

ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT

Applicant Arthrex, Inc.

K number K061665

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HWC 2006-07-18

KALIX II IMPLANT

Applicant New Deal, S.A.

K number K061765

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HWC 2006-07-05

LIGAFIX INTERFERENCE SCREW

Applicant Sciences For Bio Materials

K number K061262

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HWC 2006-06-19

ACUTE BONE SCREW

Applicant Acute Innovations, LLC

K number K061206

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HWC 2006-06-15

MILAGRO INTERFERENCE SCREW

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K060830

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HWC 2006-06-12

ULTRATINE FOREHEAD

Applicant Coapt Systems, Inc.

K number K060249

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HWC 2006-06-12

ULTRATINE TRANSBLEPH

Applicant Coapt Systems, Inc.

K number K060248

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HWC 2006-06-09

TRIDENT ANCHOR

Applicant Johnson & Johnson Company

K number K060914

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HWC 2006-06-06

MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR

Applicant Arthrotek, Inc.

K number K060693

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HWC 2006-06-06

FASTIN RC ANCHOR

Applicant Depuy Mitek

K number K060664

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HWC 2006-05-19

ARTHREX BIO-COMPRESSION SCREW

Applicant Arthrex, Inc.

K number K060478

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HWC 2006-05-04

SPIRALOK ANCHOR

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K060271

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HWC 2006-04-26

UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS

Applicant Zimmer, Inc.

K number K060710

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HWC 2006-04-18

SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS

Applicant Smith & Nephew, Inc.

K number K060736

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