Appliance, Fixation, Spinal Intervertebral Body

FDA product code KWQ · 626 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3060
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-21 – 2026-09-24

KWQ 2001-11-26

C3 ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spine Vision, Inc.

K number K012881

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KWQ 2001-11-16

MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

Applicant Aesculap, Inc.

K number K011556

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KWQ 2001-08-22

MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sulzer Spine-Tech

K number K012305

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KWQ 2001-07-20

MACROPORE OS SPINAL SYSTEM

Applicant Macropore Biosurgery, Inc.

K number K010911

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KWQ 2001-05-30

CONVERGENCE CERVICAL SPINAL SYSTEM

Applicant Spinal Innovations, LLC

K number K010639

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KWQ 2001-05-16

TETHER ACFS

Applicant Theken Surgical,Llc

K number K010466

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KWQ 2001-05-08

MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

Applicant Aesculap, Inc.

K number K002824

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KWQ 2001-04-16

REFLEX ANTERIOR CERVICAL PLATE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K010115

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KWQ 2001-01-31

EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

Applicant Ebi, L.P.

K number K010003

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KWQ 2000-10-30

SYNTHES USS (10.0MM SIDE OPENING SCREWS)

Applicant Synthes

K number K003061

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KWQ 2000-10-23

MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM

Applicant Ebi, L.P.

K number K002980

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KWQ 2000-10-13

XIA SPINE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K002858

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KWQ 2000-10-06

INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Interpore Cross Intl.

K number K002592

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KWQ 2000-09-15

K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

Applicant Spineology, Inc.

K number K002371

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KWQ 2000-08-24

ANTERIOR CERVICAL PLATE SYSTEM

Applicant Encore Orthopedics, Inc.

K number K001847

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KWQ 2000-07-20

SYNTHES CERVIFIX SYSTEM

Applicant Synthes Spine

K number K001864

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KWQ 2000-07-20

MODIFICATION TO OMEGA 21 SYSTEM

Applicant Ebi, L.P.

K number K001357

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KWQ 2000-07-19

MODIFICATION TO CENTAUR SPINAL SYSTEM

Applicant Howmedica Osteonics Corp.

K number K001844

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KWQ 2000-07-12

EBI ANTERIOR CERVICAL PLATE SYSTEM

Applicant Ebi, L.P.

K number K001794

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KWQ 2000-06-19

ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K994239

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KWQ 2000-06-07

WINDOW CERVICAL DYNAMIC PLATE SYSTEM

Applicant Advanced Spine Technology, Inc.

K number K993066

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KWQ 2000-05-11

XIA SPINE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K001272

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KWQ 2000-04-26

DELTALOC ANTERIOR CERVICAL PLATE SYSTEM

Applicant Alphatec Mfg., Inc.

K number K993513

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KWQ 2000-04-14

ABC CERVICAL PLATING SYSTEM

Applicant Aesculap, Inc.

K number K000486

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KWQ 2000-03-29

SYNTHES ANTERIOR CSLP SYSTEM

Applicant Synthes Spine

K number K000742

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KWQ 2000-03-15

CENTAUR SPINAL SYSTEM

Applicant Howmedica Osteonics Corp.

K number K994347

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KWQ 2000-03-15

SYNTHES ANTERIOR CSLP SYSTEM

Applicant Synthes Spine

K number K000536

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KWQ 2000-03-10

ROD TO ROD CROSS BRACES

Applicant Corin USA

K number K000634

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KWQ 2000-03-10

SPIRAL RADIUS RODDING SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K000009

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KWQ 2000-03-07

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

Applicant Ebi, L.P.

K number K000513

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KWQ 2000-02-18

BONE GRAFT WASHER, MODEL 9090114 - 9090118

Applicant Danek Medical, Inc.

K number K994122

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KWQ 2000-02-04

DOGBONE ACFS

Applicant Theken Surgical

K number K994383

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KWQ 2000-02-04

WILTSE SYSTEM

Applicant Advanced Spine Fixation Systems, Inc.

K number K992012

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KWQ 1999-12-29

MODIFICATION TO ISOLA SPINAL SYSTEM

Applicant Depuyacromed

K number K993030

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KWQ 1999-12-27

K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

Applicant Spineology, Inc.

K number K990959

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KWQ 1999-12-15

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Danek Medical, Inc.

K number K993855

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KWQ 1999-12-10

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

Applicant Ebi, L.P.

K number K993822

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KWQ 1999-11-16

XIA SPINAL SYSTEM C-C ADAPTOR

Applicant Howmedica Osteonics Corp.

K number K992792

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KWQ 1999-10-27

NEXT GENERATION RODDING SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K992784

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KWQ 1999-10-22

HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS

Applicant Howmedica Osteonics Corp.

K number K993181

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KWQ 1999-09-23

MOSS MIAMI 6.35MM POLYAXIAL SCREW

Applicant Depuyacromed

K number K992168

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KWQ 1999-09-14

PREMIER ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sofamor Danek USA

K number K992110

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KWQ 1999-08-12

WHITESIDE BIOMECHANICS SPINAL SYSTEM

Applicant Whiteside Biomechanics, Inc.

K number K991678

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KWQ 1999-07-30

OSTEONICS ACCP SYSTEM LINE EXTENSION

Applicant Howmedica Osteonics Corp.

K number K992344

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KWQ 1999-04-29

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

Applicant Electro-Biology, Inc.

K number K991092

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KWQ 1999-03-25

OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM

Applicant Osteonics Corp.

K number K982798

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KWQ 1999-03-10

MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM

Applicant Danek Medical, Inc.

K number K990603

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KWQ 1999-02-24

XIA SPINE SYSTEM

Applicant Howmedica, Inc.

K number K984251

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KWQ 1999-02-12

SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinal Concepts, Inc.

K number K990005

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KWQ 1999-01-20

MICOMED - HALM ZIELKE INSTRUMENTATION

Applicant Micomed GmbH

K number K982006

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KWQ 1999-01-19

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

Applicant Danek Medical, Inc.

K number K982875

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KWQ 1998-12-30

ANTERIOR CERVICAL PLATING SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K984342

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KWQ 1998-12-30

BODYFORM THORACO-LUMBAR FIXATION SYSTEM

Applicant Theken Surgical,Llc

K number K983622

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KWQ 1998-12-22

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)

Applicant United States Surgical, A Division of Tyco Healthc

K number K983899

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KWQ 1998-07-29

DOC VENTRAL CERVICAL STABILIZATION SYSTEM

Applicant Depuy Motech Acromed

K number K982443

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KWQ 1998-06-17

BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM

Applicant Blackstone Medical, Inc.

K number K974885

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KWQ 1998-05-27

SIMAL CERVICAL STABILIZATION SYSTEM

Applicant Top Surgical Products GmbH

K number K981008

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KWQ 1998-04-14

UNIVERSITY PLATE ANTERIOR SYSTEM

Applicant Acromed Corp.

K number K980228

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KWQ 1998-03-16

ORION ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K973854

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KWQ 1998-03-13

AESCULAP ABC CERVICAL PLATING SYSTEM

Applicant Aesculap, Inc.

K number K974706

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KWQ 1998-03-05

KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS

Applicant Acromed Corp.

K number K974757

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KWQ 1998-03-02

SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM

Applicant Synthes Spine

K number K974525

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KWQ 1998-02-19

MICHELSON ANTERIOR CERVICAL PLATE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K974435

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KWQ 1998-01-13

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

Applicant Ebi Electro Biology

K number K973923

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KWQ 1997-11-03

DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM

Applicant Depuy, Inc.

K number K973060

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KWQ 1997-11-03

DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy, Inc.

K number K971730

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KWQ 1997-10-16

SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

Applicant Synthes (Usa)

K number K971883

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KWQ 1997-10-01

M-2 ANTERIOR PLATE SYSTEM

Applicant Acromed Corp.

K number K972718

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KWQ 1997-08-14

TITANIUM SPINAL ROD SYSTEM

Applicant Smith & Nephew, Inc., Orthopaedic Div.

K number K970635

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KWQ 1997-08-01

SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)

Applicant Synthes (Usa)

K number K970048

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KWQ 1997-07-30

DUAL ROD ANTERIOR FIXATOR SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K963780

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KWQ 1997-06-11

KANEDA SR ANTERIOR SPINAL SYSTEM

Applicant Acromed Corp.

K number K971248

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KWQ 1997-06-11

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM

Applicant Acromed Corp.

K number K970955

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KWQ 1997-05-02

ACPII ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K970806

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KWQ 1997-05-02

EBI SPINELINK SYSTEM

Applicant Electro-Biology, Inc.

K number K964797

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KWQ 1997-04-03

ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM

Applicant Acromed Corp.

K number K970462

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KWQ 1997-03-17

LIBERTY ANTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K965193

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KWQ 1997-03-17

SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

Applicant Synthes (Usa)

K number K964416

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KWQ 1997-02-19

ANTERIOR DYNAMIZED SYSTEM

Applicant Acromed Corp.

K number K953978

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KWQ 1997-02-06

TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K964623

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KWQ 1996-12-27

DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM

Applicant Depuy, Inc.

K number K962486

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KWQ 1996-11-27

CD HORIZON ANTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K963655

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KWQ 1996-03-13

EBI ANTERIOR CERVICAL SPINE SYSTEM

Applicant Electro-Biology, Inc.

K number K955730

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KWQ 1996-01-30

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION

Applicant Sofamor Co.

K number K940744

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KWQ 1995-11-09

CODMAN ANTERIOR CERVICAL PLATE SYSTEM

Applicant Johnson & Johnson Professionals, Inc.

K number K953730

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KWQ 1995-11-06

COHORT(TM) ANTERIOR PLATE SYSTEM (APS)

Applicant Cohort Medical Products Group, Inc.

K number K950011

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KWQ 1995-11-02

AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION

Applicant Aesculap, Inc.

K number K953720

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KWQ 1995-10-25

SYNERGY TI ANTERIOR SPINAL SYSTEM

Applicant Cross Medical Products, Inc.

K number K950709

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KWQ 1995-10-11

J.B.S. ANTERIOR SPINE SYSTEM(R)

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

K number K950209

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KWQ 1995-08-25

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

Applicant Synthes Spine

K number K943725

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KWQ 1995-07-20

SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

Applicant Synthes (Usa)

K number K945700

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KWQ 1995-02-09

ISOLA ANTERIOR SYSTEM

Applicant Acromed Corp.

K number K943819

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KWQ 1995-02-08

EBI ANTERIOR CERVICAL SPINE SYSTEM

Applicant Electro-Biology, Inc.

K number K943694

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KWQ 1994-12-19

ANTERIOR CERVIAL PLATING SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K943523

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KWQ 1994-12-05

WEBB-MORLEY SPINE SYSTEM

Applicant Electro-Biology, Inc.

K number K941367

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KWQ 1994-11-08

CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM

Applicant Codman & Shurtleff, Inc.

K number K934756

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KWQ 1994-10-20

ANTERIOR SPINE SYSTEM

Applicant Buckman Co., Inc.

K number K934429

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KWQ 1994-08-15

CASPAR TITANIUM ALLOY BONE SCREWS

Applicant Aesculap, Inc.

K number K936269

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KWQ 1994-08-04

SPINE-TECH CERVICAL FIXATION SYSTEM

Applicant Spinal Technologies

K number K931653

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KWQ 1993-11-05

SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE

Applicant Synthes (Usa)

K number K925351

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