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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 1993-07-26

ACUTRACT

Applicant Acu Med, Inc.

K number K930834

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HWC 1993-04-06

TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE

Applicant Techmedica, Inc.

K number K926579

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HWC 1993-04-01

M3 LAG SCREW FIXATION SYSTEM

Applicant Osteomed Corp.

K number K924018

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HWC 1993-03-31

ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW

Applicant Ace Orthopedic Manufacturing Co.

K number K926047

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HWC 1993-03-19

3.5MM UNIVERSAL COMPRESSION SCREW

Applicant Howmedica Corp.

K number K923477

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HWC 1993-03-12

BIOACTION LOW PROFILE SCREW SYSTEM

Applicant Orthopaedic Biosystems

K number K922788

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HWC 1993-02-09

ARTHREX CANNULATED INTERFERENCE SCREW

Applicant Arthrex, Inc.

K number K915424

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HWC 1992-10-13

ACUFEX FIXATION POST

Applicant Acufex Microsurgical, Inc.

K number K924514

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HWC 1992-10-09

ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW

Applicant Alphatec Mfg., Inc.

K number K923256

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HWC 1992-08-06

ALPHATEC SMALL FRAGMENT SET

Applicant Alphatec Mfg., Inc.

K number K922166

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HWC 1992-08-05

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW

Applicant Alphatec Mfg., Inc.

K number K922322

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HWC 1992-05-01

CONCEPT ENDOSTEAL FIXATION DEVICE

Applicant Concept, Inc.

K number K912640

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HWC 1992-02-28

CORTICAL BONE SCREW

Applicant Dow Corning Wright

K number K915448

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HWC 1992-02-14

AAP BONE SCREW

Applicant Aap International, Ltd.

K number K915316

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HWC 1992-02-13

BONE SCREW 3.5 MM

Applicant Acu Med, Inc.

K number K915613

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HWC 1992-02-11

UNIVERSAL COMPRESION SCREW

Applicant Howmedica Corp.

K number K915124

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HWC 1992-01-24

M. KUROSAKA(TM) FIXATION SCREW

Applicant Depuy, Inc.

K number K913210

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HWC 1992-01-13

OREGON FIXATION SCREW

Applicant Acu Med, Inc.

K number K910976

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HWC 1991-12-19

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW

Applicant Techmedica, Inc.

K number K915187

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HWC 1991-12-05

ALPHATEC CANNULATED BONE SCREWS

Applicant Alphatec Mfg., Inc.

K number K914004

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HWC 1991-11-27

ACE CORTICAL BONE SCREW

Applicant Ace Medical Co.

K number K912598

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HWC 1991-11-22

OSTEO BONE SCREWS

Applicant Fred C. Bryson

K number K913269

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HWC 1991-11-22

MAKAR MINI CANNULATED CANCELLOUS SCREWS

Applicant Instrument Makar, Inc.

K number K912021

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HWC 1991-10-29

AESCULAP TITANIUM BONE SCREWS

Applicant Aesculap, Inc.

K number K913415

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HWC 1991-10-04

AMSET(TM) BONE SCREW

Applicant Advanced Med/Surg, Inc.

K number K911768

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HWC 1991-08-23

HUENE FIXATION SCREW

Applicant Acu-Med, Inc.

K number K910193

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HWC 1991-06-28

UNIVERSAL COMPRESSION SCREW

Applicant Howmedica Corp.

K number K904809

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HWC 1991-06-27

ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM

Applicant Howmedica Corp.

K number K911398

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HWC 1991-01-30

ACE 3.5MM CORTICAL BONE SCREW

Applicant Ace Medical Co.

K number K905048

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HWC 1991-01-04

CANCELLOUS SCREW

Applicant O'Tec Corp.

K number K905358

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HWC 1991-01-04

CORTICAL BONE SCREW (EUROPEAN STYLE)

Applicant O'Tec Corp.

K number K905357

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HWC 1991-01-04

U.S. TYPE CRUCIATE SLOT BONE SCREW

Applicant O'Tec Corp.

K number K905333

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HWC 1990-10-16

ACE CANNULATED CORTICAL BONE SCREW

Applicant Ace Medical Co.

K number K903811

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HWC 1990-10-16

ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW

Applicant Ace Medical Co.

K number K903810

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HWC 1990-10-10

LEVTECH BONE SCREW

Applicant Levtech, Inc.

K number K901144

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HWC 1990-08-21

MCGRATH ORTHOPAEDIC BONE SCREWS

Applicant Mcgrath Surgical , Ltd.

K number K901814

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HWC 1990-08-09

KNOWLES PIN

Applicant Onyx Medical Corp.

K number K903259

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HWC 1990-08-09

HAGIE PIN

Applicant Onyx Medical Corp.

K number K903258

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HWC 1990-08-09

CORTICAL BONE SCREW (EUROPEAN STYLE)

Applicant Onyx Medical Corp.

K number K903255

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HWC 1990-08-09

U.S. TYPE CRUCIATE SLOT BONE SCREW

Applicant Onyx Medical Corp.

K number K903254

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HWC 1990-08-09

CANCELLOUS SCREW

Applicant Onyx Medical Corp.

K number K903253

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HWC 1990-07-30

LAG SCREW

Applicant Onyx Medical Corp.

K number K903244

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HWC 1990-06-20

CANNULATED INTERFERENCE SCREW SYSTEM

Applicant Smith & Nephew Dyonics, Inc.

K number K901616

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HWC 1990-03-28

ACUFEX STERILE CANNULATED INTERFERENCE SCREW;

Applicant Acufex Microsurgical, Inc.

K number K900132

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HWC 1990-01-09

ACUFEX INTERFERENCE SCREW, STERILE

Applicant Acufex Microsurgical, Inc.

K number K895711

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HWC 1989-12-06

EXACTECH BONE SCREW

Applicant Exactech, Inc.

K number K896601

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HWC 1989-11-24

DEPUY (TM) TRUE COMPRESSION SCREW

Applicant Depuy, Inc.

K number K895389

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HWC 1989-11-09

CROSS CANCELLOUS BONE SCREW

Applicant Buckman Co., Inc.

K number K896044

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HWC 1989-11-08

ASNIS II GUIDED BONE SCREW

Applicant Howmedica Corp.

K number K895766

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HWC 1989-10-20

CYPRESS MEDICAL BONE SCREW & PLATES

Applicant Cypress Medical Mfg., Inc.

K number K894719

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HWC 1989-09-12

CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM

Applicant Orthopedic Systems, Inc.

K number K895219

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HWC 1989-09-12

CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM

Applicant Orthopedic Systems, Inc.

K number K895218

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HWC 1989-09-12

CORTICAL SCREW

Applicant Orthopedic Systems, Inc.

K number K895217

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HWC 1989-09-11

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS

Applicant Osteonics Corp.

K number K894124

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HWC 1989-08-30

CYPRESS CANNULATED BONE SCREW

Applicant Cypress Medical Mfg., Inc.

K number K894830

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HWC 1989-08-21

DEPUY CANNULATED BONE SCREW

Applicant Depuy, Inc.

K number K893512

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HWC 1989-08-07

VECSEI EXPANDING SCREW

Applicant Howmedica Corp.

K number K892925

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HWC 1989-06-22

REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW

Applicant Ace Medical Co.

K number K892214

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HWC 1988-10-13

CASF CANCELLOUS BONE SCREW, BT650

Applicant Terray Manufacturing, Inc.

K number K882934

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HWC 1988-10-12

ACUFEX INTERFERENCE SCREW AND SCREWDRIVER

Applicant Acufex Microsurgical, Inc.

K number K883910

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HWC 1988-08-01

ACE CANCELLOUS BONE SCREW

Applicant Buckman Co., Inc.

K number K882831

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HWC 1988-05-25

STUART CANNULATED CANCELLOUS BONE FIXATION SCREW

Applicant Stuart Drug & Surgical Supply, Inc.

K number K881327

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HWC 1988-03-07

INTERFERENCE SCREW

Applicant Concept, Inc.

K number K874676

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HWC 1988-01-20

ACROMED CANCELLOUS BONE SCREW

Applicant Buckman Co., Inc.

K number K875053

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HWC 1988-01-07

ORTHOMET BONE SCREWS

Applicant Orthomet, Inc.

K number K875050

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HWC 1987-12-17

ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW

Applicant Buckman Co., Inc.

K number K874670

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HWC 1987-12-11

ACE CORTICAL LAG SCREW

Applicant Buckman Co., Inc.

K number K874672

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HWC 1987-12-07

TITANIUM BONE SCREWS

Applicant Orthopedic Systems, Inc.

K number K874130

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HWC 1987-11-24

ACE SELFTAPPING CANCELLOUS BONE SCREW

Applicant Ace Medical Co.

K number K874593

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HWC 1987-09-18

OMNIFIT BONE SCREW

Applicant Osteonics Corp.

K number K873251

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HWC 1987-08-17

ACE CANCELLOUS BONE SCREW

Applicant Ace Medical Co.

K number K872859

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HWC 1987-07-30

CORTICAL BONE SCREWS

Applicant Military Engineering, Inc.

K number K872738

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HWC 1987-07-21

CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM

Applicant Concept, Inc.

K number K872156

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HWC 1987-03-25

CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW

Applicant Concept, Inc.

K number K871037

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HWC 1987-02-03

URESIL T-SYSTEM BONE SCREWS

Applicant Uresil Corp.

K number K870141

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HWC 1986-12-18

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM

Applicant Howmedica Corp.

K number K864633

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HWC 1986-12-15

CANCELLOUS BONE SCREW

Applicant Dow Corning Wright

K number K864626

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HWC 1986-08-29

WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW

Applicant Buckman Co., Inc.

K number K862230

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HWC 1986-03-05

MONOFIXATEUR

Applicant Ortopedia GmbH

K number K854336

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HWC 1986-02-19

REESE ARTHRODESIS SCREW

Applicant Osteotomy Guide Co.

K number K860323

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HWC 1986-02-07

ACROMED CANCELLOUS BONE SCREW

Applicant Buckman Co., Inc.

K number K860017

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HWC 1986-01-21

MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P

Applicant Advanced Biosearch Assn.

K number K855031

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HWC 1985-12-27

LINK CORTICAL SCREWS

Applicant Link America, Inc.

K number K854827

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HWC 1985-12-27

LINK CANCELLOUS SCREWS

Applicant Link America, Inc.

K number K854826

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HWC 1985-12-09

TITANIUIM BONE SCREW

Applicant George Tiemann & Co.

K number K853869

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HWC 1985-05-22

FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER

Applicant Warsaw Orthopedic, Inc.

K number K852026

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HWC 1985-05-20

ORTHOPEDIC IMPLANT SCREWS

Applicant Kirkstil Corp., Inc.

K number K850024

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HWC 1985-04-22

T-SCREW

Applicant Northeast Iowa Podiatry

K number K851214

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HWC 1985-04-19

INTERMEDICS BONE SCREW

Applicant Intermedics Orthopedics

K number K850770

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HWC 1983-08-12

BONE SCREW

Applicant W. L. Gore & Associates, Inc.

K number K831873

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HWC 1981-03-11

BONE FIXACTION SCREW

Applicant Serrano Intl.

K number K810497

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HWC 1981-02-09

MECRON CANCELLOUS CANNULATED BONE SCREWS

Applicant Serrano Intl.

K number K810205

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HWC 1979-12-06

SEIDEL INTRAMEDULLARY PLUG

Applicant Howmedica Corp.

K number K792205

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HWC 1979-10-26

HERBERT BONE SCREW

Applicant Zimmer, Inc.

K number K792022

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HWC 1978-02-23

ORTHOPEDIC DEVICES

Applicant Biomet, Inc.

K number K780235

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HWC 1977-01-14

SCREW, WADSWORTH OLECRANON

Applicant Orthopedic Equipment Co., Inc.

K number K770035

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