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 2012-11-07

Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE

Applicant Z-Medical GmbH & Co. KG

K number K121277

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HWC 2012-10-09

NEXTRA TI HAMMERTOE CORRECTION SYSTEM

Applicant Nextremity Solutions, LLC

K number K122031

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HWC 2012-10-04

ACTIVE SCREW BONE SCREW

Applicant Intelligent Implant Systems, LLC

K number K121682

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HWC 2012-09-27

PMT BONE SCREWS

Applicant Providence Medical Technology, Inc.

K number K121713

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HWC 2012-08-20

SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D

Applicant Medical Design, LLC

K number K121148

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HWC 2012-07-18

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM

Applicant Extremity Medical, LLC

K number K121417

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HWC 2012-07-18

IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER

Applicant Extremity Medical, LLC

K number K121349

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HWC 2012-06-05

CITIEFFE-TITANIUM CANNULATED SCREW

Applicant Citieffe

K number K113388

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HWC 2012-05-25

I-FUSE HAMMER TOE SYSTEMS

Applicant Orthopro, LLC

K number K113006

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HWC 2012-05-17

MINI CANNULATED HEADED AND HEADLESS SCREW SET

Applicant Instratek, Inc.

K number K120493

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HWC 2012-05-11

HEALIX ADVANCE PEEK ANCHOR

Applicant Depuy Mitek

K number K120449

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HWC 2012-04-24

PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION

Applicant Wrightmedicaltechnologyinc

K number K120645

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HWC 2012-04-10

SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET

Applicant Solana Surgical, LLC

K number K120390

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HWC 2012-01-23

SYNDE-LOCK SYNDESMOSIS REPAIR KIT

Applicant Tarsus Medical, Inc.

K number K111971

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HWC 2012-01-13

MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL

Applicant Medical Facets

K number K112727

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HWC 2012-01-04

DYNA LOCKING CANNULATED SCREW

Applicant U&I Corp.

K number K112240

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HWC 2011-12-22

COLS PEEK

Applicant Fournitures Hospitalieres Industrie

K number K113591

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HWC 2011-12-20

IFS SUBTALAR IMPLANT

Applicant Internal Fixation Systems, Inc.

K number K113399

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HWC 2011-12-19

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY

Applicant Zimmer, Inc.

K number K112885

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HWC 2011-12-19

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Applicant Ortho Solutions Limited

K number K110895

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HWC 2011-12-13

HEADLESS COMPRESSION SCREW

Applicant Skeletal Dynamics, LLC

K number K112672

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HWC 2011-12-12

OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM

Applicant Osteospring Medical, Inc.

K number K112658

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HWC 2011-12-09

RENOVIS CANNULATED SCREW SYSTEM

Applicant Renovis Surgical Technologies, LLC

K number K113084

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HWC 2011-12-09

SI-LOK SACROILIAC JOINT FIXATION SYSTEM

Applicant Globus Medical, Inc.

K number K112028

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HWC 2011-12-06

DISCO SUBTALAR IMPLANT

Applicant Trilliant Surgical, Ltd.

K number K111834

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HWC 2011-12-05

SYNTHES CORTICAL SCREWS

Applicant Synthes (USA) Products, LLC

K number K112583

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HWC 2011-11-29

BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

Applicant Biomet Microfixation, Inc.

K number K111908

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HWC 2011-10-20

TIGER HEADLESS CANNULATED SCREWS

Applicant Trilliant Surgical, Ltd.

K number K112737

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HWC 2011-10-11

SMITH & NEPHEW CANNULATED SCREWS AND WASHERS

Applicant Smith & Nephew, Inc.

K number K111994

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HWC 2011-10-07

ORTHOLOC(TM) BONE SCREWS

Applicant Wrightmedicaltechnologyinc

K number K112772

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HWC 2011-10-05

ZIMMER PERIARTICULAR SCREWS

Applicant Zimmer, Inc.

K number K111447

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HWC 2011-09-02

MICROSUTURE ANCHORS

Applicant Arthrex, Inc.

K number K112237

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HWC 2011-08-29

SLIC SCREW REPAIR SYSTEM

Applicant Acumed, LLC

K number K111608

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HWC 2011-08-19

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

Applicant Ascension Orthopedic

K number K111799

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HWC 2011-08-09

METASURG SUBTALAR IMPLANT

Applicant Metasurg

K number K111265

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HWC 2011-07-28

PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR

Applicant Parcus Medical, LLC

K number K111000

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HWC 2011-07-28

N-FORCE FIXATION SYSTEM

Applicant Innovision, Inc.

K number K102528

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HWC 2011-07-25

3.7MM/5.0MM DYNAMIC LOCKING SCREW

Applicant Synthes USA

K number K110592

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HWC 2011-07-21

METASURG DIGIFUSE IMPLANT

Applicant Metasurg

K number K111536

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HWC 2011-07-20

AAP CANNULATED SCREWS

Applicant Aap Implantate AG

K number K111316

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HWC 2011-07-12

PRO FIXATION SYSTEM

Applicant Synovis Orthopedic & Woundcare

K number K110538

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HWC 2011-06-02

APTUS CANNULATED COMPRESSION SCREWS

Applicant Medartis AG

K number K110658

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HWC 2011-05-24

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

Applicant Synthes (USA) Products, LLC

K number K111230

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HWC 2011-05-17

STERILE STORM (R) OPERATING KIT

Applicant Intelligent Orthopaedics, Ltd.

K number K111001

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HWC 2011-05-04

ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K102324

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HWC 2011-04-11

LATARJET CORTICAL SCREW SET

Applicant T.A.G. Medical Products Corporation, Ltd.

K number K110763

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HWC 2011-03-18

LOW PROFILE SCREWS

Applicant Arthrex, Inc.

K number K103705

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HWC 2011-03-17

FLEXFUSION (TM) FIXATION IMPLANT

Applicant Nextremity Solutions, LLC

K number K110445

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HWC 2011-03-11

GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K103712

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HWC 2011-02-08

TRILLIANT SURGICAL SUBTALAR IMPLANT

Applicant Trilliant Surgical, Ltd.

K number K103183

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HWC 2011-01-07

TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K102298

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HWC 2010-12-21

MATRYX INTERFERENCE SCREW (5.0-6.5MM)

Applicant Conmed Linvatec

K number K102410

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HWC 2010-11-23

EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM

Applicant Emerge Medical

K number K102343

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HWC 2010-11-23

LOCKING BONE SCREW MODEL HCQ04, HCZ04

Applicant Changzhou Orthmar Medical Instrument Co., Ltd.

K number K100721

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HWC 2010-11-22

CSTS SCREW

Applicant Orthopro, LLC

K number K093055

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HWC 2010-11-15

PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR

Applicant Parcus Medical, LLC

K number K102326

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HWC 2010-11-10

PARCUS PEEK CF PUSH-IN SUTURE ANCHOR

Applicant Parcus Medical, LLC

K number K102162

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HWC 2010-11-08

SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER

Applicant Medshape Solutions

K number K101808

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HWC 2010-10-20

PIONEER CANNULATED SCREW SYSTEM

Applicant Pioneer Surgical Technology, Inc.

K number K102903

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HWC 2010-10-12

IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM

Applicant Extremity Medical, LLC

K number K101700

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HWC 2010-09-10

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

Applicant Zimmer, Inc.

K number K101696

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HWC 2010-07-23

PRO-TOE VO HAMMERTOW IMPLANT SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K101165

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HWC 2010-07-15

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

Applicant Tecnologia Y Diseno Industrial, S.A DE C.V

K number K101254

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HWC 2010-06-24

DARCO HEADED CANNULATED SCREW

Applicant Wrightmedicaltechnologyinc

K number K100359

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HWC 2010-06-23

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS

Applicant Bonutti Research, Inc.

K number K093078

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HWC 2010-06-03

MODIFICATION TO HBS HEADLESS BONE SCREW

Applicant Biopro, Inc.

K number K101030

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HWC 2010-05-19

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

Applicant Memometal Technologies

K number K093820

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HWC 2010-05-04

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES

Applicant Smith & Nephew, Inc.

K number K100325

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HWC 2010-04-28

EXTREMITY MEDICAL SCREW SYSTEM

Applicant Extremity Medical, LLC

K number K093770

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HWC 2010-03-19

OPUS SPEEDSCREW SYSTEM

Applicant Arthrocare Corp.

K number K100457

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HWC 2010-03-17

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K100532

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HWC 2010-03-17

OMNITECH LARGE, TRIMED COMPRESSION SCREW

Applicant TriMed, Inc.

K number K093676

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HWC 2010-01-19

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061

Applicant Small Bone Innovations, Inc.

K number K092754

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HWC 2010-01-11

SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)

Applicant Synthes (Usa)

K number K092909

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HWC 2009-12-16

FOOT AND HAND MOTION SYSTEM

Applicant Newclip Technics

K number K091118

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HWC 2009-11-13

LEFORTE NEUROSYSTEM BONE SCREW

Applicant Jeil Medical Corporation

K number K091686

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HWC 2009-11-05

ASCENSION CANNULATED SCREW SYSTEM

Applicant Ascension Orthopedics, Inc.

K number K092440

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HWC 2009-11-05

ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N

Applicant Arthrocare Corp.

K number K092133

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HWC 2009-10-02

SYNERGY CANNULATED SCREW SYSTEM

Applicant Synergy Surgical Technologies, LLC

K number K092082

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HWC 2009-09-30

PARCUS PPEK CF INTERFERENCE SCREW

Applicant Parcus Medical, LLC

K number K091093

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HWC 2009-09-18

POGO SCREW

Applicant Fxdevices

K number K092189

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HWC 2009-09-16

WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,

Applicant Medshape Solutions

K number K091202

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HWC 2009-09-10

UNITY BETA PLLA SYSTEM

Applicant Bonutti Research, Inc.

K number K090175

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HWC 2009-09-02

MERETE COMPRESSION SCREWS

Applicant Merete Medical GmbH

K number K091798

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HWC 2009-07-31

SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS

Applicant Synthes (Usa)

K number K090949

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HWC 2009-07-24

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM

Applicant Extremity Medical, LLC

K number K091577

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HWC 2009-07-15

TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS

Applicant Treu-Instrumente GmbH

K number K083912

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HWC 2009-07-07

MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)

Applicant Tag Medical Products

K number K091694

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HWC 2009-06-03

INTERTAN CHS LIMITED COLLAPSE SET SCREW

Applicant Smith & Nephew, Inc.

K number K090656

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HWC 2009-06-01

MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT

Applicant Medacta International S.A.

K number K091069

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HWC 2009-05-26

FUSION MEDICAL CANNULATED SCREW SYSTEM

Applicant John Riccio

K number K081122

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HWC 2009-05-20

FUSION MEDICAL STI

Applicant John Riccio

K number K081755

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HWC 2009-05-06

LIGAFIX INTERFACE SCREW

Applicant Science For Biomaterials

K number K090994

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HWC 2009-04-23

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM

Applicant Extremity Medical, LLC

K number K082934

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HWC 2009-04-17

LATARJET CORTICAL SCREW SET

Applicant Tag Medical Products

K number K083096

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HWC 2009-03-25

WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055

Applicant Medshape Solutions

K number K083792

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HWC 2009-03-12

UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM

Applicant U.S. Implant Solutions, LLC

K number K081813

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HWC 2009-03-06

PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020

Applicant Parcus Medical, LLC

K number K083619

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HWC 2009-03-04

APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM

Applicant Cayenne Medical, Inc.

K number K083612

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HWC 2009-03-04

APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM

Applicant Cayenne Medical, Inc.

K number K083607

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