Appliance, Fixation, Spinal Interlaminal

FDA product code KWP · 408 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3050
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-09-27 – 2013-12-11

KWP 2001-09-24

XIA STAINLESS STEEL SYSTEM

Applicant Howmedica Osteonics Corp.

K number K012870

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KWP 2001-09-13

SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177

Applicant Interpore Cross Intl.

K number K012871

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KWP 2001-07-23

TRI-FIX SPINAL FIXATION SYSTEM

Applicant Endius, Inc.

K number K011830

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KWP 2001-07-19

SYNTHES CERVIFIX SYSTEM

Applicant Synthes (Usa)

K number K011969

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KWP 2001-07-18

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

Applicant Depuyacromed

K number K010681

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KWP 2001-07-11

SCS DT-02 TRANSVERSE CONNECTOR

Applicant Ortho Tec, LLC

K number K003823

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KWP 2001-06-12

CD HORIZON SPINAL SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K011508

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KWP 2001-06-12

CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION

Applicant Medtronic Sofamor Danek, Inc.

K number K010181

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KWP 2001-05-31

BUTTERFLY PLATE FUNCTION SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K010632

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KWP 2001-03-22

MODIFICATION TO SYNERGY SPINAL SYSTEM

Applicant Interpore Cross Intl.

K number K010515

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KWP 2001-03-20

ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION

Applicant Ortho Tec, LLC

K number K001535

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KWP 2001-03-13

TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)

Applicant Terray Corp.

K number K003911

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KWP 2001-01-24

PARSFIX CABLE-SCREW SYSTEM

Applicant Spinal Concepts, Inc.

K number K003351

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KWP 2001-01-08

ISOLA CLOSED DUAL ROD CONNECTOR

Applicant Depuyacromed

K number K003822

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KWP 2000-12-15

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

Applicant Depuyacromed

K number K002733

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KWP 2000-11-13

AMT SPINAL SYSTEM

Applicant Micron Precision Engineering, Inc.

K number K002059

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KWP 2000-11-02

SIMPLICITY SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K002103

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KWP 2000-10-16

MODIFICATION TO ISOBAR SPINAL SYSTEM

Applicant Encore Orthopedics, Inc.

K number K002959

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KWP 2000-10-06

SPEEDLINK TRANSVERSE CONNECTOR

Applicant Spinal Concepts, Inc.

K number K002082

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KWP 2000-10-05

XIA SPINE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K002505

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KWP 2000-10-05

ASCEND SPINAL FIXATION SYSTEM

Applicant Spinal Innovations, LLC

K number K002069

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KWP 2000-09-12

MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS

Applicant Depuyacromed

K number K002607

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KWP 2000-09-12

USS VAS

Applicant Synthes (Usa)

K number K002517

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KWP 2000-08-18

XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY

Applicant Howmedica Osteonics Corp.

K number K001653

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KWP 2000-08-04

E-Z LINK CROSS CONNECTOR

Applicant Depuyacromed

K number K001470

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KWP 2000-07-27

E-Z LINK CROSS CONNECTOR

Applicant Depuyacromed

K number K001372

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KWP 2000-06-29

SPINE SYSTEM EVOLUTION

Applicant Aesculap, Inc.

K number K001080

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KWP 2000-06-16

DYNA-LOK CLASSIC SPINAL SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K001532

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KWP 2000-04-24

MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS

Applicant Depuyacromed

K number K001105

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KWP 1999-12-21

SYNTHES CERVIFIX SYSTEM

Applicant Synthes (Usa)

K number K994187

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KWP 1999-11-19

VERSALOK LOW BACK FIXATION SYSTEM

Applicant Osteotech, Inc.

K number K992885

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KWP 1999-11-16

SILHOUETTE SPINAL FIXATION SYSTEM

Applicant Sulzer Spine-Tech

K number K993067

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KWP 1999-11-08

TITANIUM HARTSHILL SYSTEM

Applicant Surgicraft , Ltd.

K number K991662

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KWP 1999-10-14

CONTOUR SPINAL SYSTEM

Applicant Ortho Development Corp.

K number K990986

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KWP 1999-08-27

DYNA-LOK PLUS SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K991198

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KWP 1999-08-27

SYNTHES CERVIFIX SYSTEM

Applicant Synthes Spine

K number K991089

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KWP 1999-07-23

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

Applicant Osteotech, Inc.

K number K991586

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KWP 1999-07-01

SYNTHES CERVIFIX SYSTEM

Applicant Synthes (Usa)

K number K990965

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KWP 1999-06-02

OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR

Applicant Howmedica Osteonics Corp.

K number K990922

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KWP 1999-04-30

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY

Applicant Osteonics Corp.

K number K984375

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KWP 1999-04-29

EBI OMEGA 21 SYSTEM

Applicant Electro-Biology, Inc.

K number K990303

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KWP 1999-04-13

MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15

Applicant Advanced Spine Fixation Systems, Inc.

K number K990845

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KWP 1999-03-30

TITANIUM VERSALOK

Applicant Wrightmedicaltechnologyinc

K number K990708

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KWP 1999-01-28

CD HORIZON SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K981676

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KWP 1999-01-21

SYNTHES SPINE CERVIFIX SYSTEM

Applicant Synthes (Usa)

K number K984377

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KWP 1998-12-22

ROGOZINSKI SPINAL ROD SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K983904

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KWP 1998-12-18

SCS SPINAL SYSTEM

Applicant Orthotec, Inc.

K number K983353

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KWP 1998-12-16

SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM

Applicant Synthes (Usa)

K number K983530

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KWP 1998-12-03

DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS

Applicant Depuy, Inc.

K number K983583

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KWP 1998-11-25

SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM

Applicant Synthes (Usa)

K number K982322

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KWP 1998-11-19

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089

Applicant Ohio Medical Instrument Co., Inc.

K number K983282

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KWP 1998-11-12

MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K983706

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KWP 1998-10-26

SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)

Applicant United States Surgical, A Division of Tyco Healthc

K number K983197

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KWP 1998-10-05

TENOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K982490

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KWP 1998-09-14

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS

Applicant Depuy, Inc.

K number K982511

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KWP 1998-09-14

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K982320

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KWP 1998-09-08

BWM SPINE SYSTEM

Applicant Howmedica Corp.

K number K982494

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KWP 1998-08-28

MODIFICATION TO EBI SPINELINK SYSTEM

Applicant Electro-Biology, Inc.

K number K982908

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KWP 1998-08-06

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K982011

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KWP 1998-07-29

SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM

Applicant Spine-Tech, Inc.

K number K980288

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KWP 1998-06-10

AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS

Applicant Aesculap, Inc.

K number K980121

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KWP 1998-05-20

OSTEONICS LONG ARM CONTAINMENT RING

Applicant Osteonics Corp.

K number K981452

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KWP 1998-05-11

SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM

Applicant Synthes Spine

K number K980928

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KWP 1998-04-16

SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM

Applicant Synthes (Usa)

K number K980358

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KWP 1998-02-18

DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K974573

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KWP 1998-01-08

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

Applicant Osteotech, Inc.

K number K973868

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KWP 1997-10-16

CD SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K964159

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KWP 1997-08-07

RANSFORD CERVICAL FIXATION SYSTEM

Applicant Surgicraft , Ltd.

K number K965221

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KWP 1997-07-16

BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED

Applicant Arcan Orthopaedic Corp.

K number K971457

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KWP 1997-06-18

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

Applicant Osteotech, Inc.

K number K971289

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KWP 1997-05-08

EMPOWER ANTERIOR DIRECT SCREWS

Applicant Smith & Nephew Richards, Inc.

K number K965224

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KWP 1997-04-21

TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K964254

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KWP 1997-03-26

BACFIX SPINAL FIXATION SYSTEM

Applicant Spinal Concepts, Inc.

K number K964404

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KWP 1997-03-26

DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K964024

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KWP 1997-03-18

MOSS MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K962628

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KWP 1997-03-13

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K965145

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KWP 1997-02-06

TITANIUM CD HORIZON SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K962708

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KWP 1997-01-24

FINN ROD TO ROD CONNECTOR

Applicant Smith & Nephew Richards, Inc.

K number K960444

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KWP 1997-01-14

ALPHA POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K964275

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KWP 1996-12-09

HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM

Applicant Osteonics Corp.

K number K962314

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KWP 1996-12-05

CD HORIZON SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K961633

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KWP 1996-11-27

ISOLA PEDIATRIC COMPONENTS

Applicant Acromed Corp.

K number K962984

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KWP 1996-11-14

ACROMED PEDICLE SCREW

Applicant Acromed Corp.

K number K963639

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KWP 1996-10-01

COTREL-DUBOUSSET (CD) SPINAL

Applicant Sofamor Danek USA,Inc.

K number K955807

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KWP 1996-03-27

COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K955365

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KWP 1996-03-15

J.B. S. C1-C2 CLAMP

Applicant J.B.S., S.A.

K number K955864

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KWP 1996-03-13

BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)

Applicant Arcan Orthopaedic Corp.

K number K955927

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KWP 1996-03-11

ROGOZINSKI THORACOLUMBAR SPINAL ROD

Applicant Smith & Nephew Richards, Inc.

K number K954696

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KWP 1996-02-16

TITANIUM MOSS MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K955348

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KWP 1996-02-14

MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS

Applicant Alphatec Mfg., Inc.

K number K951846

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KWP 1996-02-09

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

Applicant Osteotech, Inc.

K number K955173

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KWP 1996-02-09

CD LIBERTY POSTERIOR SPINCAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K951164

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KWP 1996-01-25

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM

Applicant Advanced Spine Fixation Systems, Inc.

K number K954770

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KWP 1996-01-16

TITANIUM GDLH POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K954645

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KWP 1995-12-19

CLAMP ASSEMBLY

Applicant J.B.S., S.A.

K number K953599

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KWP 1995-12-19

SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS

Applicant Sofamor Danek Mfg., Inc.

K number K936294

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KWP 1995-07-11

J.B.S. CERVICAL SPINE SYSTEM

Applicant J.B.S., S.A.

K number K942432

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KWP 1995-06-22

WEBB-MORLEY SPINE SYSTEM

Applicant Electro-Biology, Inc.

K number K945781

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KWP 1995-05-31

BRYAN POSTERIOR SPINAL FIXATOR (BPSF)

Applicant Arcan Orthopaedic Corp.

K number K945435

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KWP 1995-05-15

APOFIX CERVICAL SPINE FIXATION

Applicant Sofamor Co.

K number K945022

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