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 2003-10-08

ENDOTINE FOREHEAD DEVICE

Applicant Coapt Systems, Inc.

K number K032770

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HWC 2003-10-07

ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

Applicant Arthrex, Inc.

K number K032098

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HWC 2003-10-01

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE

Applicant Arthrotek, Inc.

K number K032072

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HWC 2003-09-22

ARTHREX TRIMIT SCREW, MODEL AR-4161B

Applicant Arthrex, Inc.

K number K031945

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HWC 2003-09-04

ALANTECH GRAFT FIXATION SCREW

Applicant Arthrocare Corp.

K number K031937

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HWC 2003-08-22

OSTEOMED SUBTALAR IMPLANT SYSTEM

Applicant Osteomed LP

K number K031155

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HWC 2003-08-11

LORENZ 2.4 SELF DRILLING SCREWS

Applicant Walter Lorenz Surgical, Inc.

K number K032228

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HWC 2003-08-08

BIORCI SCREW

Applicant Smith & Nephew, Inc.

K number K032224

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HWC 2003-08-08

HBS HEADLESS BONE SCREW

Applicant Schoening & Assoc., Inc.

K number K030302

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HWC 2003-07-14

PCW PERCUTANEOUS COMPRESSION WIRE

Applicant Millennium Medical Technologies, Inc.

K number K031050

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HWC 2003-07-01

TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318

Applicant Smith & Nephew, Inc.

K number K031685

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HWC 2003-06-26

RAPIDFIRE SELF DRILLING SCREWS

Applicant Walter Lorenz Surgical, Inc.

K number K031751

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HWC 2003-06-26

MINILOK QUICKANCHOR PLUS

Applicant Mitek Worldwide

K number K030995

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HWC 2003-06-19

INION OTPS BIODEGRADABLE FIXATON SYSTEM

Applicant Inion , Ltd.

K number K030900

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HWC 2003-06-02

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX

Applicant Karl Storz Endoscopy

K number K030848

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HWC 2003-05-30

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

Applicant Inion , Ltd.

K number K023887

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HWC 2003-04-24

IMPACT SUTURE ANCHOR. MODEL 433510

Applicant Bionx Implants, Ltd.

K number K030388

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HWC 2003-04-18

LEFORTE SYSTEM BONE SCREW

Applicant Jeil Medical Corporation

K number K023365

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HWC 2003-03-20

EBI DYNAFIX COMPRESSION BONE SCREW

Applicant Ebi, L.P.

K number K030706

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HWC 2003-03-20

KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW

Applicant KARL STORZ Endoscopy-America, Inc.

K number K030368

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HWC 2003-03-20

STRYKER BIOZIP SUTURE ANCHOR

Applicant Stryker Endoscopy

K number K023192

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HWC 2003-03-13

MICROFIX QUICKANCHOR PLUS

Applicant Mitek Worldwide

K number K024115

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HWC 2003-02-26

STRYKER XCEL ANCHOR SYSTEM

Applicant Stryker Endoscopy

K number K023013

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HWC 2003-02-06

KOMPRESSOR SCREW SYSTEM

Applicant Kinetikos Medical, Inc.

K number K024233

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HWC 2003-01-09

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM

Applicant Biomet Orthopedics, Inc.

K number K024086

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HWC 2002-12-20

MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

Applicant Howmedica Osteonics Corp.

K number K024060

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HWC 2002-12-20

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

Applicant Coapt Systems, Inc.

K number K023922

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HWC 2002-12-09

AAP CANNULATED SCREWS

Applicant Aap Implantate AG

K number K021233

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HWC 2002-12-02

MODULAR HEAD BONE SCREW

Applicant Biomet, Inc.

K number K022952

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HWC 2002-10-18

1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM

Applicant Osteomed Corp.

K number K023260

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HWC 2002-10-17

BIOSTEON CROSS PIN

Applicant Biocomposites, Ltd.

K number K021351

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HWC 2002-10-09

BOSWORTH CORACO-CLAVICULAR SCREW

Applicant Howmedica Osteonics Corp.

K number K023294

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HWC 2002-10-04

NUGEN FX SCREW

Applicant Bionx Implants, Inc.

K number K023022

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HWC 2002-10-04

MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

Applicant Smith & Nephew, Inc.

K number K023021

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HWC 2002-10-03

ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

Applicant Arthrex, Inc.

K number K022234

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HWC 2002-09-12

INION CPS 2.5/2.8 SCREW

Applicant Inion , Ltd.

K number K022981

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HWC 2002-09-06

STAYFUSE GT-IP

Applicant Pioneer Surgical Technology

K number K022726

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HWC 2002-09-06

SYNTHES 6.5 MM CANNULATED SCREW

Applicant Synthes (Usa)

K number K021932

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HWC 2002-09-05

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM

Applicant Triad Medical, Inc.

K number K022647

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HWC 2002-08-12

MAGLY 6.5MM CANNULATED SCREWS

Applicant Magly Orthopedics, LLC

K number K021662

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HWC 2002-08-09

MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM

Applicant Magly Orthopedics, LLC

K number K021579

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HWC 2002-08-09

SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW

Applicant Synthes (Usa)

K number K021556

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HWC 2002-07-29

WISORB MALLEOLAR SCREW

Applicant Cambridge Scientific, Inc.

K number K020222

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HWC 2002-07-17

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

Applicant Inion , Ltd.

K number K021280

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HWC 2002-07-17

LACTOSORB MINI INTERFERENCE SCREW

Applicant Biomet Orthopedics, Inc.

K number K021254

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HWC 2002-07-01

BIOFASTIN RC THREADED SUTURE ANCHOR

Applicant Mitek Worldwide

K number K021883

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HWC 2002-07-01

SMALL HAMMER TOE PIN

Applicant Biomet, Inc.

K number K021828

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HWC 2002-06-26

ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER

Applicant Biomet, Inc.

K number K021832

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HWC 2002-06-26

DUET SUTURE ANCHOR

Applicant Bionx Implants, Ltd.

K number K020056

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HWC 2002-06-25

TITANIUM CANNULATED INTERFERENCE SCREW

Applicant Future Medical Systems, Inc.

K number K021030

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HWC 2002-06-11

BIOSCREW XTRALOK

Applicant Linvatec Corp.

K number K013131

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HWC 2002-06-06

HBS HEADLESS BONE SCREW

Applicant Millennium Medical Technologies, Inc.

K number K020791

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HWC 2002-05-06

PRE-LOADED BIOSTINGER HORNET

Applicant Linvatec Corp.

K number K020377

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HWC 2002-04-02

4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

Applicant Arthrex, Inc.

K number K020043

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HWC 2002-03-27

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

Applicant Triage Medical, Inc.

K number K014304

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HWC 2002-03-26

SMITH & NEPHEW TWINFIX TI QUICK T

Applicant Smith & Nephew, Inc.

K number K020159

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HWC 2002-03-26

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050

Applicant Triage Medical, Inc.

K number K014243

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HWC 2002-03-18

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00

Applicant Vilex, Inc.

K number K014154

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HWC 2002-03-15

COAPT SYSTMES ENDOTINE DEVICE

Applicant Coapt Systems, Inc.

K number K014153

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HWC 2002-03-14

MITEK BIOCRYL INTERFERENCE SCREWS

Applicant Mitek Products

K number K013572

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HWC 2002-03-13

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM

Applicant American Medical Systems, Inc.

K number K020446

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HWC 2002-02-28

LORENZ SELF DRILLING SCREWS

Applicant Walter Lorenz Surgical, Inc.

K number K013954

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HWC 2002-02-26

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

Applicant Unitedstates Surgical

K number K020352

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HWC 2002-02-26

BIOABSORBABLE INTERFERENCE SCREW MEGAFIX

Applicant Karl Storz Endoscopy

K number K013107

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HWC 2002-02-22

INION CPS BSSO SCREW

Applicant Inion , Ltd.

K number K020266

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HWC 2002-02-13

AOS CANNULATED BONE SCREW SYSTEM

Applicant Advanced Orthopaedic Solutions, Inc.

K number K014185

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HWC 2002-01-18

PLLA CANNULATED INTERFERENCE SCREW

Applicant Future Medical Systems, Inc.

K number K013685

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HWC 2001-12-17

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2

Applicant Triad Medical, Inc.

K number K013903

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HWC 2001-12-17

DRG ORTHOHEX SS BONE SCREW

Applicant Doctor'S Research Group, Inc.

K number K013786

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HWC 2001-12-17

SELF-COUNTERSINKING BONE SCREW

Applicant Biomet Orthopedics, Inc.

K number K013534

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HWC 2001-12-11

SURGICAL DYNAMICS MENISCAL STAPLE

Applicant United States Surgical, A Division of Tyco Healthc

K number K013890

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HWC 2001-12-10

REUNITE FUSION SCREW

Applicant Biomet, Inc.

K number K011451

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HWC 2001-12-03

SYNTHES 3.9 MM PELVIC SCREWS

Applicant Synthes (Usa)

K number K013044

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HWC 2001-12-03

SYNTHES 2.4 MM CANNULATED SCREW

Applicant Synthes (Usa)

K number K012945

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HWC 2001-12-03

SOFT TISSUE SCREW AND WASHER

Applicant Biomet, Inc.

K number K012572

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HWC 2001-12-03

RESORBABLE NO PROFILE SCREW AND WASHER

Applicant Biomet Manufacturing, Inc.

K number K012469

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HWC 2001-11-21

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

Applicant Bionx Implants, Inc.

K number K013546

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HWC 2001-11-20

RESORBABLE SCREW ANCHOR

Applicant Arthrotek, Inc.

K number K012872

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HWC 2001-11-20

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX

Applicant Triage Medical, Inc.

K number K012818

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HWC 2001-11-20

HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED

Applicant Triage Medical, Inc.

K number K012817

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HWC 2001-11-16

INTEX SCREW

Applicant Biomet, Inc.

K number K012798

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HWC 2001-09-06

MODIFICATION TO THE I.C.O.S SCREW

Applicant New Deal, S.A.

K number K011821

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HWC 2001-08-24

THE SPIN SNAP-OFF SCREW

Applicant New Deal, S.A.

K number K011946

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HWC 2001-08-17

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

Applicant Triage Medical, Inc.

K number K012280

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HWC 2001-08-03

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM

Applicant Aesculap, Inc.

K number K011102

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HWC 2001-08-01

CANNULATED PLUS SCREW SYSTEM

Applicant Orthomatrix, Inc.

K number K010738

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HWC 2001-07-18

SMARTSCREW

Applicant Bionx Implants, Ltd.

K number K012001

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HWC 2001-07-18

1.5MM BONE FIXATION KIT

Applicant Bionx Implants, Ltd.

K number K012000

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HWC 2001-07-13

IN-FAST BONE SCREW SYSTEM

Applicant American Medical Systems, Inc.

K number K011910

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HWC 2001-07-05

AUTO-DRIVE LAG SCREW SYSTEM

Applicant Osteomed Corp.

K number K010964

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HWC 2001-07-02

PLUS CANCELLOUS BONE SCREWS

Applicant Plus Orthopedics

K number K011719

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HWC 2001-06-20

TITANIUM COMPRESSION ANCHOR SYSTEM

Applicant Anchor Medical Technologies

K number K010884

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HWC 2001-06-15

MODIFICATION TO THE BOLD SCREW

Applicant New Deal, S.A.

K number K011262

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HWC 2001-05-30

2.0/2.4 CANNULATED SCREW SYSTEM

Applicant Osteomed Corp.

K number K010783

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HWC 2001-05-29

DJ ORTHOPEDICS POST SCREW

Applicant Dj Orthopedics, LLC

K number K010594

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HWC 2001-05-25

MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

Applicant Bionx Implants, Inc.

K number K010554

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HWC 2001-05-23

ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM

Applicant Arthrex, Inc.

K number K010525

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HWC 2001-05-09

RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM

Applicant Mitek Products

K number K010633

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HWC 2001-05-08

DJ ORTHOPEDICS INTERFERENCE SCREW

Applicant Dj Orthopedics, LLC

K number K010595

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HWC 2001-04-26

SMARTSCREW MODEL 222006...227510

Applicant Bionx Implants, Ltd.

K number K003077

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