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 2009-04-28

PIONEER LUMBAR PLATE SYSTEM

Applicant Pioneer Surgical Technology

K number K090222

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KWQ 2009-04-07

MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM

Applicant Lanx, Inc.

K number K090316

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KWQ 2009-04-02

BLACK WIDOW ANTERIOR BUTTRESS PLATE

Applicant Omni Surgical, L.P.

K number K081770

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KWQ 2009-03-26

STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM

Applicant Stryker Corp.

K number K083020

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KWQ 2009-03-25

STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM

Applicant Stryker Corp.

K number K083562

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KWQ 2009-03-20

NUVASIVE HELIX-T ACP SYSTEM

Applicant Nuvasive, Inc.

K number K083341

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KWQ 2009-02-25

PACP

Applicant Pioneer Surgical Technology

K number K083663

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KWQ 2009-02-02

CARDIFF ANTERIOR CERVICAL PLATE SYSTEM

Applicant Seaspine, Inc.

K number K083338

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KWQ 2009-01-29

ANTERIOR BUTTRESS PLATE

Applicant Scient'X USA, Inc.

K number K081548

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KWQ 2009-01-27

APOLLO ANTERIOR CERVICAL PLATE SYSTEM

Applicant Apollo Spine, Inc.

K number K082504

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KWQ 2008-11-19

THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS

Applicant K2m, Inc.

K number K081380

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KWQ 2008-11-13

BIOMET ANTERIOR LUMBAR PLATE

Applicant Ebi, L.P.

K number K082187

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KWQ 2008-10-31

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spine Smith Partners L.P.

K number K082821

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KWQ 2008-09-26

SEEPLATE CERVICAL PLATE SYSTEM

Applicant Amedica Corp.

K number K082037

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KWQ 2008-09-24

NUVASIVE LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K082070

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KWQ 2008-09-10

UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K082273

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KWQ 2008-09-02

ANTEGRA-T

Applicant Synthes Spine Co.Lp

K number K081568

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KWQ 2008-08-15

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Medtronic Sofamor Danek

K number K081038

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KWQ 2008-07-14

SPINAL ELEMENTS BUTTRESS PLATE SYSTEM

Applicant Spinal Elements, Inc.

K number K081418

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KWQ 2008-07-14

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spine Smith Partners L.P.

K number K081132

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KWQ 2008-07-03

VERTEBRON SSP CERVICAL PLATING SYSTEM

Applicant Vertebron, Inc.

K number K081567

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KWQ 2008-07-03

VIP ANTERIOR CERVICAL PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K081391

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KWQ 2008-07-03

ACTIVE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sanacor

K number K073500

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KWQ 2008-06-09

THOR ANTERIOR PLATING SYSTEM

Applicant Stryker Spine

K number K080773

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KWQ 2008-06-03

FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM

Applicant Precision Surgery , Ltd.

K number K073708

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KWQ 2008-05-23

ARCOFIX

Applicant Synthes Spine Co.Lp

K number K080020

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KWQ 2008-05-02

C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

Applicant Biomet Spine

K number K080646

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KWQ 2008-04-30

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K080429

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KWQ 2008-04-28

TRANS1 AXIALIF 2-LEVEL OR II SYSTEM

Applicant Trans1 Incorporated

K number K073643

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KWQ 2008-04-25

MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM

Applicant Theken Spine, LLC

K number K080690

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KWQ 2008-04-23

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM

Applicant Signus Medizintechnik GmbH

K number K080815

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KWQ 2008-04-02

EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K080191

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KWQ 2008-03-24

CAYMAN BUTTRESS PLATE SYSTEM

Applicant K2m, Inc.

K number K080302

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KWQ 2008-02-20

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX

Applicant Spinefrontier, Inc.

K number K073232

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KWQ 2008-02-13

THOR ANTERIOR PLATING SYSTEM

Applicant Stryker Spine

K number K073437

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KWQ 2008-02-13

RELIANCE BUTTRESS WASHER SYSTEM

Applicant Reliance Medical Systems, LLC

K number K073349

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KWQ 2008-01-31

ACCIN ANTERIOR CERVICAL PLATE SYSTEM

Applicant Accelerated Innovation, LLC

K number K073530

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KWQ 2008-01-29

NUVASIVE HELIX MINI ACP SYSTEM

Applicant Nuvasive, Inc.

K number K073275

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KWQ 2008-01-28

BUTREX BUTTRESS PLATING SYSTEM

Applicant X-Spine Systems, Inc.

K number K072943

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KWQ 2008-01-11

TRANS1 AXIAL FIXATON SYSTEM

Applicant Trans1 Incorporated

K number K073514

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KWQ 2008-01-10

PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM

Applicant Pioneer Surgical Technology

K number K072703

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KWQ 2008-01-09

KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM

Applicant Life Spine

K number K073479

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KWQ 2007-12-28

POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

Applicant Lanx, LLC

K number K071905

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KWQ 2007-12-26

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)

Applicant Esm Technologies, LLC

K number K072231

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KWQ 2007-12-21

BODYFORM THORACIC FIXATION SYSTEM

Applicant Theken Spine, LLC

K number K072407

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KWQ 2007-11-30

SYNTHES VECTRA-ONE SYSTEM

Applicant Synthes Spine

K number K071667

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KWQ 2007-11-28

IST ANTERIOR CERVICAL PLATE SYSTEM

Applicant Innovative Spinal Technologies, Inc.

K number K072650

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KWQ 2007-11-07

TENSION BAND ANTERIOR SPINAL SYSTEM

Applicant Spinal Instrumentation Simplification Systems, LLC

K number K071151

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KWQ 2007-11-01

PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K071416

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KWQ 2007-10-29

VALEO CERVICAL PLATE SYSTEM

Applicant Amedica Corp.

K number K071990

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KWQ 2007-10-19

NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K072339

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KWQ 2007-10-05

SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K072546

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KWQ 2007-09-19

MODIFICATION TO SPINAL USA VBR SYSTEM

Applicant Spinal USA

K number K070922

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KWQ 2007-08-08

NUVASIVE HELIX ACP SYSTEM

Applicant Nuvasive, Inc.

K number K071329

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KWQ 2007-08-03

C-JAWS CERVICAL COMPRESSIVE MINI FRAME

Applicant Medicrea Technologies

K number K072040

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KWQ 2007-07-31

GRAFT CONTAINMENT DEVICE

Applicant Nuvasive, Inc.

K number K070148

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KWQ 2007-06-11

ALTIVA CLASSIC ACP SYSTEM

Applicant Altiva Corp.

K number K070891

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KWQ 2007-05-30

OSSTAPLE, OSSPLATE, OSSFORCE

Applicant Biomedical Enterprises, Inc.

K number K061385

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KWQ 2007-05-16

SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM

Applicant Southern Spine, LLC

K number K063764

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KWQ 2007-05-09

EAGLE + ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K070994

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KWQ 2007-05-04

NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM

Applicant Alphatec Spine, Inc.

K number K070681

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KWQ 2007-04-19

MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K070775

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KWQ 2007-04-16

SIMPLEX CERVICAL FIXATION SYSTEM

Applicant Pisharodi Surgicals, Inc.

K number K070335

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KWQ 2007-04-03

MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K070273

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KWQ 2007-03-22

ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

Applicant Stryker Spine

K number K063430

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KWQ 2007-03-13

LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Life Spine

K number K070285

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KWQ 2007-02-23

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE

Applicant Medtronic Sofamor Danek, Inc.

K number K063100

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KWQ 2007-02-14

MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM

Applicant K2m, Inc.

K number K063544

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KWQ 2007-01-18

NUVASIVE ACP4 SYSTEM

Applicant Nuvasive, Inc.

K number K062590

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KWQ 2006-12-19

CITADEL ANTERIOR LUMBAR PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K062836

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KWQ 2006-12-04

PREVIEW ANTERIOR CERVICAL PLATE SYSTEM

Applicant Alphaspine, Inc.

K number K062371

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KWQ 2006-11-16

KINETIC ANTERIOR CERVICAL PLATE

Applicant Life Spine

K number K062643

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KWQ 2006-11-15

MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

Applicant U&I Corp.

K number K061002

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KWQ 2006-11-14

SYNTHES ANTEGRA SYSTEM

Applicant Synthes Spine Co.Lp

K number K063158

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KWQ 2006-10-19

MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

Applicant Life Spine

K number K062831

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KWQ 2006-10-05

UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM

Applicant Advanced Spine Technology, Inc.

K number K062686

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KWQ 2006-09-06

GATEWAY THORACOLUMBAR PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K062407

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KWQ 2006-08-30

TRINICA ANTERIOR LUMBAR PLATE SYSTEM

Applicant Zimmer Spine, Inc.

K number K061353

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KWQ 2006-08-18

REFLEX HYBRID ACP SYSTEM

Applicant Stryker Spine

K number K062310

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KWQ 2006-08-16

VERTEBRON SCP CERVICAL PLATE SYSTEM

Applicant Vertebron, Inc.

K number K062110

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KWQ 2006-08-10

LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K061789

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KWQ 2006-07-26

ALTES BUTTRESS PLATING SYSTEM

Applicant Altiva Corp.

K number K061482

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KWQ 2006-07-24

UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM

Applicant Blackstone Medical, Inc.

K number K061229

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KWQ 2006-06-30

OPTERYX ANTERIOR CERVICAL PLATE SYSTEM

Applicant Innovasis, Inc.

K number K061147

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KWQ 2006-05-25

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Medtronic Sofamor Danek

K number K061274

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KWQ 2006-05-15

PYRENEES CERVICAL PLATE SYSTEM

Applicant K2m, LLC

K number K060442

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KWQ 2006-04-18

SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinal USA

K number K060025

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KWQ 2006-03-13

QUANTUM ANTERIOR CERVICAL PLATE SYSTEM

Applicant Quantum Orthopedics, Inc.

K number K060491

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KWQ 2006-03-06

EBI ANTERIOR CERVICAL PLATE SYSTEM

Applicant Ebi, L.P.

K number K060379

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KWQ 2006-02-17

NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM

Applicant Nuvasive, Inc.

K number K053581

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KWQ 2006-02-03

AEGIS ANTERIOR LUMBAR PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K052546

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KWQ 2005-11-16

PACP SYSTEM

Applicant Pioneer Surgical Technology

K number K053053

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KWQ 2005-11-10

STELLA CERVICAL PLATE

Applicant Scient'X

K number K052763

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KWQ 2005-10-21

SPIDER CERVICAL PLATING (SCP) SYSTEM

Applicant X-Spine Systems, Inc.

K number K052292

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KWQ 2005-10-17

MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

Applicant Vertebron, Inc.

K number K051815

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KWQ 2005-10-17

TECTONIC CERVICAL PLATE SYSTEM

Applicant K2m, LLC

K number K051531

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KWQ 2005-10-13

HYBRID ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K052552

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KWQ 2005-09-09

SYNTHES VECTRA-T SYSTEM

Applicant Synthes Spine

K number K051665

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KWQ 2005-08-29

THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES

Applicant Abbott Spine, Inc.

K number K052072

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KWQ 2005-08-04

OPTIMA SPINAL SYSTEM

Applicant U&I Corp.

K number K051971

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