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 2013-10-08

ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)

Applicant Life Spine, Inc.

K number K132589

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KWQ 2013-09-06

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST

Applicant Medos International SARL

K number K132324

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KWQ 2013-09-03

SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Applicant Accel Spine

K number K132366

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KWQ 2013-08-29

TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM

Applicant Zimmer Spine, Inc.

K number K132012

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KWQ 2013-08-29

ASPIRON ACP SYSTEM

Applicant U&I Corporation

K number K131200

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KWQ 2013-08-29

NUVASIVE DECADE LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K130868

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KWQ 2013-08-23

TEMPUS(TM) CERVICAL PLATE SYSTEM

Applicant Neurostructures, LLC

K number K131374

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KWQ 2013-08-07

KATIA SYSTEM

Applicant Shanghai Sanyou Medical Co, Ltd.

K number K131512

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KWQ 2013-07-11

NEXUS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Core-Nexus

K number K131520

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KWQ 2013-06-05

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM

Applicant Pioneer Surgical Technology, Inc.

K number K130427

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KWQ 2013-06-04

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K130640

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KWQ 2013-05-07

AZURE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Orthofix, Inc.

K number K130825

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KWQ 2013-04-29

IRIS ANTERIOR CERVICAL PLATE

Applicant Life Spine, Inc.

K number K130202

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KWQ 2013-04-25

ZAVATION CERVICAL PLATE SYSTEM

Applicant Zavation, LLC

K number K130030

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KWQ 2013-02-01

ANTERIOR CERVICAL PLATE SYSTEM

Applicant Weigao Orthopaedic Device Co., Ltd.

K number K123578

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KWQ 2013-02-01

NUVASIVE LONG LATERAL SPINAL SYSTEM

Applicant Nuvasive, Inc.

K number K122081

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KWQ 2012-12-28

DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM

Applicant Medos International SARL

K number K123167

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KWQ 2012-12-14

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Corelink, LLC

K number K121514

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KWQ 2012-12-07

V2F ANTERIOR FIXATION SYSTEM

Applicant Zimmer Spine, Inc.

K number K122733

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KWQ 2012-11-19

ZOU ANTERIOR LUMBAR PLATE SYSTEM

Applicant Corelink, LLC

K number K121791

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KWQ 2012-10-31

REX ANTERIOR CERVICAL PLATE SYSTEM

Applicant Dio Medical Co., Ltd.

K number K121862

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KWQ 2012-10-23

NUVASIVE SAGE LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K121815

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KWQ 2012-10-15

ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM

Applicant Medical Design, LLC

K number K122497

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KWQ 2012-10-11

ARCHON ANTERIOR CERVICAL PLATE SYSTE,

Applicant Nu Vasive, Incorporated

K number K122910

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KWQ 2012-09-13

VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM

Applicant Accel Spine

K number K121078

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KWQ 2012-09-11

QUINTEX CERVICAL PLATING SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K121801

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KWQ 2012-09-05

RELIANCE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Reliance Medical Systems, LLC

K number K122216

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KWQ 2012-07-20

ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)

Applicant Orthofix, Inc.

K number K121658

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KWQ 2012-07-18

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE

Applicant Medicrea International

K number K121323

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KWQ 2012-07-16

NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K121837

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KWQ 2012-07-11

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinal USA, LLC

K number K112748

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KWQ 2012-07-03

SPINE FRONTIER INDUS ACP SYSTEM

Applicant Spinefrontier, Inc.

K number K121060

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KWQ 2012-06-27

UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K121049

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KWQ 2012-06-20

BLUE MOUNTAIN CERVICAL PLATE

Applicant Qualgenix, LLC

K number K112809

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KWQ 2012-05-23

TEMPUS CERVICAL PLATE SYSTEM

Applicant Neurostructures, LLC

K number K120515

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KWQ 2012-05-07

PIONEER LATERAL PLATE SYSTEM

Applicant Pioneer Surgical Technology, Inc.

K number K120724

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KWQ 2012-04-13

PLYMOUTH THORACOLUMBAR PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K120092

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KWQ 2012-04-06

CERVICAL PLATE

Applicant Eisertech, LLC

K number K113170

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KWQ 2012-02-24

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM

Applicant Sintea Plustek, LLC

K number K112861

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KWQ 2012-01-25

CARDIFF ANTERIOR CERVICAL PLATE SYSTEM

Applicant Seaspine, Inc.

K number K112206

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KWQ 2012-01-20

LEXUS ANTERIOR CERVICAL PLATE SYSTEM

Applicant L&K BIOMED Co., Ltd.

K number K113509

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KWQ 2012-01-17

K2M, PYRENEES CERVICAL PLATE SYSTEM

Applicant K2m, Inc.

K number K113329

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KWQ 2011-12-09

GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Genesys Spine

K number K111132

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KWQ 2011-12-08

ZAVATION CERVICAL PLATE SYSTEM

Applicant Zavation, LLC

K number K112533

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KWQ 2011-11-21

DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM

Applicant Medos International SARL

K number K112724

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KWQ 2011-10-27

INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

Applicant Zimmer Spine, Inc.

K number K111796

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KWQ 2011-08-24

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES

Applicant Pioneer Surgical Technology, Inc.

K number K111528

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KWQ 2011-08-23

PASS ANTERIOR SPINAL SYSTEM

Applicant Medicrea Technologies

K number K102406

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KWQ 2011-08-17

PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)

Applicant K2m, Inc.

K number K111135

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KWQ 2011-07-25

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

Applicant Gold Standard Orthopedics, LLC

K number K110990

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KWQ 2011-07-22

NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K111866

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KWQ 2011-06-20

NUVASIVE LONG LATERAL SPINAL SYSTEM

Applicant Nuvasive, Inc.

K number K111410

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KWQ 2011-06-01

MIS ANTERIOR CERVICAL PLATING SYSTEM

Applicant Life Spine

K number K103423

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KWQ 2011-03-15

ALTUM ANTERIOR CERVICAL PLATE

Applicant Spinecraft, LLC

K number K103505

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KWQ 2011-03-14

TRANS1 AXIALIF PLUS

Applicant Trans1 Incorporated

K number K102334

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KWQ 2011-03-03

NUVASIVE TRAVERSE PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K103750

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KWQ 2011-02-15

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM

Applicant Precision Surgery , Ltd.

K number K103838

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KWQ 2011-02-15

PSL ANTERIOR CERVICAL PLATE SYSTEM

Applicant Precision Surgery , Ltd.

K number K103819

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KWQ 2011-02-14

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM

Applicant A Johnson & Johnson Company

K number K103491

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KWQ 2011-02-10

VENUS ANTERIOR CERVICAL PLATE

Applicant Verticor, Ltd.

K number K103137

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KWQ 2011-02-04

GOLDEN GATE ANTERIOR PLATE SYSTEM

Applicant Ulrich GmbH & Co. KG

K number K101353

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KWQ 2011-02-02

POLARIS SPINAL SYSTEM

Applicant Biomet Spine

K number K103393

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KWQ 2011-01-14

KING COBRA ANTERIOR CERVICAL PLATE

Applicant Eminent Spine

K number K103068

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KWQ 2011-01-12

GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +

Applicant G Surgical Co., Ltd.

K number K103070

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KWQ 2010-11-05

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Applicant Alphatec Spine, Inc.

K number K102820

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KWQ 2010-10-14

SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinal Elements, Inc.

K number K101848

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KWQ 2010-09-29

LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM

Applicant Ldr Spine USA

K number K102265

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KWQ 2010-09-02

QUINTEX CERVICAL PLATING SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K100243

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KWQ 2010-07-21

ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM

Applicant Alphatec Spine, Inc.

K number K101255

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KWQ 2010-06-04

PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

Applicant Pioneer Surgical Technology

K number K100708

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KWQ 2010-05-21

TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Transcorp, Inc.

K number K092695

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KWQ 2010-05-21

MAMBO, MODEL CS 18XX-XX

Applicant Ulrich GmbH & Co. KG

K number K090861

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KWQ 2010-05-19

REGENT ANTERIOR CERVICAL PLATE

Applicant Custom Spine

K number K101151

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KWQ 2010-05-13

DIAMOND ANTERIOR CERVICAL PLATE SYSTEM

Applicant Amendia, Inc.

K number K100265

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KWQ 2010-05-04

HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES

Applicant Blackstone Medical, Inc.

K number K100614

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KWQ 2010-04-07

ARCHIMED REMEDY CERVICAL PLATE

Applicant Archimed, Inc.

K number K100215

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KWQ 2010-04-07

LANX ANTERIOR PLATING SYSTEM

Applicant Lanx, Inc.

K number K092765

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KWQ 2010-03-26

INDUS ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinefrontier, Inc.

K number K093776

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KWQ 2010-03-11

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS

Applicant K2m, Inc.

K number K092474

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KWQ 2010-02-19

NUVASIVE HELIX REVOLUTION ACP SYSTEM

Applicant Nuvasive, Inc.

K number K093804

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KWQ 2010-02-12

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX

Applicant K2m, Inc.

K number K100061

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KWQ 2010-02-04

UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Depuy Spine, Inc.

K number K100070

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KWQ 2010-02-04

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spine360

K number K092531

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KWQ 2010-01-22

ACP4 SPINAL IMPLANT SYSTEM

Applicant X-Spine Systems, Inc.

K number K092360

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KWQ 2010-01-21

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II

Applicant Trans1 Incorporated

K number K092124

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KWQ 2010-01-19

LIFE SPINE LUMBAR PLATE SYSTEM

Applicant Life Spine

K number K093200

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KWQ 2010-01-19

BLADE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Nexxt Medical, Inc.

K number K091936

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KWQ 2009-12-22

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

Applicant Choicespine, LP

K number K091926

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KWQ 2009-11-17

SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25

Applicant Spinal USA

K number K092659

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KWQ 2009-11-16

XTEND ANTERIOR CERVICAL PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K092146

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KWQ 2009-10-23

COMET ANTERIOR CERVICAL PLATE SYSTEM

Applicant Apollo Spine, Inc.

K number K090751

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KWQ 2009-10-06

INTERPLATE C

Applicant Rsb Spine, LLC

K number K092070

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KWQ 2009-08-17

CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE

Applicant Custom Spine, Inc.

K number K091134

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KWQ 2009-08-13

TRUSS THORACOLUMBAR PLATE SYSTEM

Applicant Globus Medical, Inc.

K number K092108

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KWQ 2009-08-05

CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM

Applicant Cardo Medical Corp.

K number K091396

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KWQ 2009-07-10

SYNTHES ORACLE PLATE

Applicant Synthes Spine

K number K091159

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KWQ 2009-07-09

SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM

Applicant Spinal USA

K number K091044

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KWQ 2009-06-04

THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS

Applicant K2m, Inc.

K number K091253

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KWQ 2009-06-01

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM

Applicant Eminent Spine

K number K090415

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KWQ 2009-05-08

NUVASIVE LATERAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K091071

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