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 1996-11-04

EZ-FIX SMALL CANNULATED SCREW SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K962987

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HWC 1996-10-10

ALTA FULLY THREADED CROSS-LOCKING SCREWS

Applicant Howmedica Corp.

K number K963398

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HWC 1996-10-10

EXTREMITY BONE SCREW

Applicant Acu Med, Inc.

K number K963118

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HWC 1996-10-03

TWIST-OFF SCREW

Applicant Landos, Inc.

K number K962233

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HWC 1996-10-01

SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER

Applicant Synthes (Usa)

K number K962823

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HWC 1996-09-20

SCARF THREAD-HEAD SCREW

Applicant Landos, Inc.

K number K962236

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HWC 1996-08-23

COMPRESSION SCREW

Applicant Orthopaedic Biosystems, Ltd.

K number K962779

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HWC 1996-08-19

INTERFERENCE SCREW

Applicant Linvatec Corp.

K number K960962

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HWC 1996-08-15

BIOSCREW ABSORBABLE INTERFERENCE SCREW

Applicant Linvatec Corp.

K number K960940

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HWC 1996-08-07

SYNTHES ANATOMICAL LOCKING PLATE SYSTEM

Applicant Synthes (Usa)

K number K961413

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HWC 1996-08-06

MEDICINELODGE, INC. SET SCREW

Applicant Medicinelodge, Inc.

K number K961905

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HWC 1996-08-05

SYNTHES 7.0/7.3 MM CANNULATED SCREWS

Applicant Synthes (Usa)

K number K962011

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HWC 1996-07-23

SUBTALAR MBA SYSTEM

Applicant Kinetikos Medical, Inc.

K number K960692

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HWC 1996-07-16

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

Applicant Smith & Nephew Endoscopy, Inc.

K number K961649

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HWC 1996-06-19

DEPUY ADVANTAGE FIXATION SCREW SYSTEM

Applicant Depuy, Inc.

K number K961234

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HWC 1996-06-06

DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS

Applicant Depuy, Inc.

K number K960704

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HWC 1996-05-17

WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW

Applicant Whiteside Biomechanics, Inc.

K number K961157

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HWC 1996-03-25

K2 BONE SCREW SYSTEM

Applicant Kinetikos Medical, Inc.

K number K960537

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HWC 1996-03-25

K3 BONE SCREW SYSTEM

Applicant Kinetikos Medical, Inc.

K number K960533

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HWC 1996-03-22

NORTHO BONE SCREW

Applicant Northo Orthopedics

K number K925872

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HWC 1996-03-04

CANNULATED PLUS HIP SCREW (STERILE)

Applicant Wrightmedicaltechnologyinc

K number K955837

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HWC 1996-03-04

J.B.S. T.T.A SCREW

Applicant J.B.S. (Usa), Inc.

K number K955710

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HWC 1996-02-15

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW

Applicant Acufex Microsurgical, Inc.

K number K954246

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HWC 1996-01-30

MLI INTERFERENCE SCREW

Applicant Medicinelodge, Inc.

K number K953350

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HWC 1996-01-25

FIXANO D.D.S. (DOUBLE SLIDING SCREW)

Applicant Ferguson Medical

K number K954757

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HWC 1996-01-25

ARTHREX BIOABSORBABLE INTERFERENCE SCREW

Applicant Arthrex, Inc.

K number K945303

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HWC 1995-12-19

GO INTRAMEDULLARY NAIL LOCKING SCREW

Applicant Genesis Orthopedics, Inc.

K number K954511

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HWC 1995-12-08

SUPER SCREW 3.5 MM

Applicant Osteomed Corp.

K number K954330

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HWC 1995-11-24

CORTICELLOUS BONE SCREW

Applicant Hayes Medical, Inc.

K number K953198

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HWC 1995-11-03

DEPUY STAINLESS STEEL SET SCREW

Applicant Depuy, Inc.

K number K953650

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HWC 1995-10-31

6.5MM SOLID CANCELLOUS BONE SCREW

Applicant Ace Medical Co.

K number K954485

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HWC 1995-09-28

STRYKER ACL INTERFERENCE SCREW SYSTEM

Applicant Stryker Endoscopy

K number K952460

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HWC 1995-09-15

BIOSCREW ABSORBABLE INTERFERENCE SCREW

Applicant Linvatec Corp.

K number K952831

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HWC 1995-09-12

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K952697

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HWC 1995-08-25

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM

Applicant American Medical Electronics, Inc.

K number K951232

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HWC 1995-08-18

SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW

Applicant Synthes (Usa)

K number K952296

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HWC 1995-07-31

TI. ALLOY 2.0 MM CORTEX SCREW

Applicant Synthes (Usa)

K number K952272

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HWC 1995-07-24

REUNION BONE SCREW SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K951389

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HWC 1995-07-18

NEXMED CANCELLOUS BONE SCREWS

Applicant Nexmed, Inc.

K number K951656

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HWC 1995-07-11

OGDEN ANCHOR

Applicant American Medical Electronics, Inc.

K number K950875

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HWC 1995-07-11

ABSORBABLE ACETABULAR SCREW

Applicant Zimmer, Inc.

K number K946347

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HWC 1995-07-11

ANSPACH SUTURE ANCHOR

Applicant The Anspach Effort, Inc.

K number K945525

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HWC 1995-07-10

DEPUY SET SCREW

Applicant Depuy, Inc.

K number K950833

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HWC 1995-07-05

ORTHOPEDIC SCREW FIXATION

Applicant Osteomed Corp.

K number K932350

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HWC 1995-07-03

OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS

Applicant American Medical Electronics, Inc.

K number K951545

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HWC 1995-07-03

OGDEN ANCHOR

Applicant American Medical Electronics, Inc.

K number K951493

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HWC 1995-07-03

LMT BONE ANCHOR

Applicant Li Medical Technologies, Inc.

K number K951472

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HWC 1995-07-03

LMT BONE ANCHOR

Applicant Li Medical Technologies, Inc.

K number K951233

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HWC 1995-07-03

HARPOON SUTURE ANCHORS

Applicant Biomet, Inc.

K number K943806

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HWC 1995-06-30

K4 BONE SCREW SYSTEM

Applicant Kinetikos Medical, Inc.

K number K950704

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HWC 1995-06-27

SFC

Applicant Medpac

K number K951303

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HWC 1995-06-22

OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS

Applicant Osteotech, Inc.

K number K950652

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HWC 1995-06-22

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

Applicant Smith and Nephew Donjoy, Inc.

K number K945687

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HWC 1995-06-16

SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER

Applicant Synthes (Usa)

K number K951304

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HWC 1995-06-14

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS

Applicant Smith & Nephew Richards, Inc.

K number K934590

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HWC 1995-05-17

MED-SURG SUTURE WASHER

Applicant Medical Surgical, Inc.

K number K950250

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HWC 1995-05-10

LINVATEC STASYS-PES FIXATION DEVICE

Applicant Linvatec Corp.

K number K934321

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HWC 1995-05-05

ACUTRAK PLUS FIXATION SYSTEM

Applicant Acu Med, Inc.

K number K944330

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HWC 1995-04-14

ARTHREX CANCELLOUS SCREW AND WASHER

Applicant Arthrex, Inc.

K number K945426

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HWC 1995-02-03

AIMS CANNULATED ACL SCREW (7MM DIAMETER)

Applicant Smith and Nephew Donjoy, Inc.

K number K945236

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HWC 1995-02-02

BONE MULCH SCREW

Applicant Biomet, Inc.

K number K941941

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HWC 1995-01-24

DYONICS FIXATION SCREWS

Applicant Smith & Nephew Dyonics, Inc.

K number K945182

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HWC 1994-12-09

6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW

Applicant Howmedica Corp.

K number K944213

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HWC 1994-12-08

BONE SCREW

Applicant Cohort Medical Products Group, Inc.

K number K943804

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HWC 1994-12-05

CANNULATED CANCELLOUS BONE SCREW

Applicant Acu Med, Inc.

K number K942341

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HWC 1994-12-05

CORTICAL BONE SCREW

Applicant Acu Med, Inc.

K number K942340

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HWC 1994-11-28

PIONEER LABORATORIES CABLE SCREW

Applicant Pioneer Surgical Technology

K number K941866

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HWC 1994-11-22

PIONEER LABORATORIES BONE SCREW

Applicant Pioneer Surgical Technology

K number K940690

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HWC 1994-10-19

AIMS CANNULATED ACL SCREW

Applicant Smith & Nephew, Inc.

K number K943539

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HWC 1994-10-14

CANNULATED BONE SCREW

Applicant Cohort Medical Products Group, Inc.

K number K943474

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HWC 1994-10-07

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER

Applicant Mitek Surgical Products, Inc.

K number K934366

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HWC 1994-09-30

INTERFERENCE SCREW

Applicant Applied Osteo Systems, Inc.

K number K943160

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HWC 1994-09-19

PIONEER LABORATORIES CABLE PIN

Applicant Pioneer Surgical Technology

K number K941174

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HWC 1994-09-01

STAPLE, FIXATION BONE; SCREW FIXATION BONE

Applicant Roseburg SA

K number K931155

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HWC 1994-08-01

ARTHROTEK SET SCREW

Applicant Biomet, Inc.

K number K932721

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HWC 1994-07-12

TITANIUM ALLOY BONE SCREWS

Applicant Aesculap, Inc.

K number K940207

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HWC 1994-05-17

BIOSCREW ABSORBABLE INTERFERENCE SCREW

Applicant Linvatec Corp.

K number K933719

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HWC 1994-05-04

CANNULATED CANCELLOUS SCREW

Applicant Onyx Medical Corp.

K number K931680

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HWC 1994-05-04

AMSET(TM) CANNULATED BONE SCREW

Applicant Advanced Med/Surg, Inc.

K number K931538

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HWC 1994-04-28

ACE 6.5 MM BONE SCREW

Applicant Ace Medical Co.

K number K931652

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HWC 1994-04-25

CANCELLOUS BONE SCREW

Applicant Onyx Medical Corp.

K number K934616

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HWC 1994-04-25

CANCELLOUS BONE SCREW

Applicant Onyx Medical Corp.

K number K934615

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HWC 1994-04-25

CORTICAL BONE SCREW

Applicant Onyx Medical Corp.

K number K931790

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HWC 1994-04-25

CANNULATED NAVICULAR SCREW

Applicant Onyx Medical Corp.

K number K931681

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HWC 1994-04-15

BONE OR INTERFERENCE SCREW

Applicant Endo Surgical Concepts, Inc.

K number K935836

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HWC 1994-03-10

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM

Applicant Smith and Nephew Donjoy, Inc.

K number K934044

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HWC 1994-03-10

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

Applicant Smith and Nephew Donjoy, Inc.

K number K932862

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HWC 1994-03-01

FULLY THREADED ALTA CANCELLOUS BONE SCREW

Applicant Howmedica Corp.

K number K931524

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HWC 1994-02-23

ARTHROTEK INTERFERENCE SCREW

Applicant Biomet, Inc.

K number K934469

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HWC 1994-02-23

M. KUROSAKA INTERFERENCE FIXATION SCREW

Applicant Depuy, Inc.

K number K933738

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HWC 1994-02-23

CONCEPT CANNULATED INTEREFERENCE SCREW

Applicant Linvatec Corp.

K number K933352

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HWC 1994-02-23

OREGON FIXATION SYSTEM INTERFERENCE SCREW

Applicant Acu Med, Inc.

K number K932027

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HWC 1994-02-22

AME UNIVERSAL BONE SCREW

Applicant American Medical Electronics, Inc.

K number K930107

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HWC 1994-02-17

6.5 MM CANCELLOUS BONE SCREW

Applicant Encore Orthopedics, Inc.

K number K931665

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HWC 1994-02-10

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW

Applicant Instrument Makar, Inc.

K number K930980

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HWC 1994-02-07

IMPLEX ACETABULAR CUP SCREW SYSTEM

Applicant Implex Corp.

K number K931187

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HWC 1994-01-07

BAUMER SCREWS

Applicant Baumer Ortopedia , Ltd.

K number K930970

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HWC 1993-10-27

ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR

Applicant Anspach Mfg., Inc.

K number K925328

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HWC 1993-10-27

BONE SCREWS

Applicant Instrument Makar, Inc.

K number K923841

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HWC 1993-08-24

INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR

Applicant Acufex Microsurgical, Inc.

K number K921481

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