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 2020-06-04

CarboClear® Cervical Plate System

Applicant CarboFix Orthopedics , Ltd.

K number K200883

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KWQ 2020-05-28

Meridian Anterior Plate System, Regatta Lateral Plate System

Applicant SeaSpine Orthopedics Corporation

K number K200885

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KWQ 2020-05-21

Insignia™ Anterior Cervical Plate System

Applicant Alphatec Spine, Inc.

K number K200995

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KWQ 2020-05-21

NuVasive Thoracolumbar Plates

Applicant Nu Vasive, Incorporated

K number K200956

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KWQ 2020-05-20

NuVasive® ACP System

Applicant Nu Vasive, Incorporated

K number K201078

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KWQ 2020-05-12

Cure™ Lumbar Plate System

Applicant Meditech Spine, LLC

K number K201136

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KWQ 2020-05-05

Balteum™ Lumbar Plate System

Applicant Huvexel Co. , Ltd.

K number K200846

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KWQ 2020-04-30

Biolign® Roto-Loc Cervical Plate System

Applicant Elite Surgical Supplies (Pty), Ltd.

K number K200523

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KWQ 2020-04-06

Origin™ Anterior Cervical Plate System

Applicant Orthopaedic & Spine Development

K number K193494

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KWQ 2020-03-24

SEA-LINK Anterior Cervical Plate System

Applicant Indius Medical Technologies Pvt. , Ltd.

K number K200224

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KWQ 2020-02-05

SpineNet SSP System

Applicant Spinenet, LLC

K number K200170

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KWQ 2019-11-20

TranS1 AxiaLIF Plus System

Applicant Trans1

K number K192792

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KWQ 2019-11-08

Oryx Cervical Plate System

Applicant Innovasis, Inc.

K number K192049

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KWQ 2019-10-29

NexGen Anterior Cervical Plate System

Applicant Precision Spine

K number K192494

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KWQ 2019-10-24

Genesys Spine Binary® Lumbar Plate System

Applicant Genesys Spine

K number K192678

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KWQ 2019-10-23

RESONATE Anterior Cervical Plate System

Applicant Globus Medical, Inc.

K number K192314

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KWQ 2019-10-22

FORTICO Anterior Cervical Fixation System

Applicant Camber Spine Technologies, LLC

K number K191584

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KWQ 2019-09-03

NuVasive® ACP System

Applicant Nu Vasive, Incorporated

K number K191500

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KWQ 2019-08-30

Cyclops™ Anterior Cervical Plate System

Applicant Degen Medical, Inc.

K number K191786

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KWQ 2019-08-29

Binary® Anterior Cervical Plate System

Applicant Genesys Spine

K number K192076

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KWQ 2019-06-12

Lateral Plate System

Applicant Corelink, LLC

K number K190016

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KWQ 2019-05-31

Cervical Plate

Applicant Eisertech, LLC

K number K190565

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KWQ 2019-05-29

Fuji Cervical Plate System

Applicant Altus Partners, LLC

K number K183084

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KWQ 2019-05-15

CAYMAN LP Plate System

Applicant K2m, Inc.

K number K190584

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KWQ 2019-05-13

MVP Cervical Plate System

Applicant GS Medical Co., Ltd.

K number K190170

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KWQ 2019-05-09

CYGNUS™ Anterior Cervical Plate System

Applicant MiRus, LLC

K number K190666

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KWQ 2019-05-01

Boomerang™ Anterior Cervical Plate System

Applicant Choicespine, LP

K number K190227

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KWQ 2019-04-19

ASSURE® Anterior Cervical Plate System

Applicant Globus Medical, Inc.

K number K183056

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KWQ 2019-03-21

CastleLoc-P Anterior Cervical Plate System

Applicant L&K BIOMED Co., Ltd.

K number K190425

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KWQ 2019-02-11

Athena II Cervical Plate System

Applicant Medyssey USA, Inc.

K number K183409

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KWQ 2019-02-11

SMG Anterior Cervical Plate System

Applicant Sapphire Medical Group

K number K183073

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KWQ 2019-02-06

Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K182885

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KWQ 2019-02-01

SECULOK™ ACP System

Applicant U&I Corporation

K number K190053

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KWQ 2019-01-17

CervAlign™ Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K number K183060

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KWQ 2019-01-17

Pinehurst Anterior Cervical Plate System

Applicant Signature Orthopaedics Pty, Ltd.

K number K181190

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KWQ 2019-01-16

4CIS® Pinehurst Anterior Cervical Plate system

Applicant Solco Biomedical Co., Ltd.

K number K182489

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KWQ 2019-01-03

Raven Lumbar Plate System

Applicant Choicespine, LP

K number K183214

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KWQ 2018-12-17

Met One Czar Anterior Cervical Plate System

Applicant Met One Technologies

K number K180772

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KWQ 2018-12-12

PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems

Applicant K2m, Inc.

K number K182473

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KWQ 2018-11-29

V3 Segmental Plating System

Applicant Atlas Spine, Inc.

K number K182418

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KWQ 2018-11-09

Aspida® Anterior Lumbar Plating System

Applicant Alphatec Spine, Inc.

K number K182808

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KWQ 2018-11-06

ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System

Applicant Globus Medical, Inc.

K number K181846

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KWQ 2018-09-10

SECULOK™ ACP System

Applicant U&I Corporation

K number K182055

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KWQ 2018-08-31

Cure™ OPEL-C Plate System

Applicant Meditech Spine, LLC

K number K181543

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KWQ 2018-08-03

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)

Applicant Curiteva, LLC

K number K181549

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KWQ 2018-08-02

Curiteva Anterior Cervical Plate System

Applicant Curiteva, LLC

K number K181562

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KWQ 2018-07-20

Athena Cervical Plate System

Applicant Medyssey USA, Inc.

K number K180022

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KWQ 2018-07-13

Kestrel™ Buttress Plate System

Applicant Innovasis, Inc.

K number K181063

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KWQ 2018-07-10

Zavation Cervical Plate System

Applicant Zavation Medical Products, LLC

K number K181244

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KWQ 2018-07-06

Vail ALIF Buttress Plate System

Applicant Evolution Spine, LLC

K number K180755

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KWQ 2018-06-22

Life Spine Lumbar Fixation System (SENTRY)

Applicant Life Spine, Inc.

K number K180166

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KWQ 2018-04-23

Cure™ Lumbar Plate System

Applicant Meditech Spine, LLC

K number K180090

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KWQ 2018-04-16

Mediant Anterior Cervical Plating System

Applicant Intelligent Implant Systems, LLC

K number K173935

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KWQ 2018-04-05

Axis Anterior Cervical Plate System

Applicant Axis Orthopaedics

K number K173867

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KWQ 2018-04-03

Genesys Spine Binary Lumbar Plate System

Applicant Genesys Spine

K number K173885

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KWQ 2018-03-27

Zavation Buttress Plate System

Applicant Zavation Medical Products, LLC

K number K180537

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KWQ 2018-02-26

TRYPTIK2 C-Plate Anterior Cervical Plate System

Applicant Spineart

K number K171797

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KWQ 2018-01-24

SeaSpine Cabo ACP (Anterior Cervical Plate) System

Applicant SeaSpine Orthopedics Corporation

K number K173521

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KWQ 2018-01-22

EZ Plate

Applicant Zavation Medical Products, LLC

K number K173306

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KWQ 2017-12-21

Anterior Cervical Plate System

Applicant Evolution Spine, LLC

K number K173375

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KWQ 2017-12-06

Boundary Anterior Lumbar Buttress Plate

Applicant Nvision Biomedical Technologies, LLC

K number K173091

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KWQ 2017-11-30

Fortis and Hana Anterior Cervical Plate System

Applicant Huvexel Co. , Ltd.

K number K173099

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KWQ 2017-10-23

Liberty Anterior Cervical Plate

Applicant Valorus Spine

K number K172585

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KWQ 2017-10-05

Shanghai Sanyou CARMEN Cervical Fusion System

Applicant Shanghai Sanyou Medical Co, Ltd.

K number K163366

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KWQ 2017-09-22

Matira™ Anterior Cervical System

Applicant Kalitec Direct, LLC

K number K172086

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KWQ 2017-08-28

2 Hole Lateral Plating System

Applicant Life Spine, Inc.

K number K172131

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KWQ 2017-08-23

Ozark(tm) Cervical Plate System

Applicant K2m, Inc.

K number K172104

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KWQ 2017-08-11

NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System

Applicant Signature Orthopaedics Pty, Ltd.

K number K163625

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KWQ 2017-07-20

EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System

Applicant Medos International SARL

K number K171439

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KWQ 2017-07-06

Spider Cervical Plating System

Applicant X-Spine Systems, Inc.

K number K170224

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KWQ 2017-06-21

Terrace™ Anterior Cervical Plate System

Applicant Corelink, LLC

K number K163104

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KWQ 2017-06-16

Cure™ Lumbar Plate System

Applicant Meditech Spine, LLC

K number K171538

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KWQ 2017-06-08

Trifore(tm) Cervical Plating System

Applicant Neurostructures, Inc.

K number K171112

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KWQ 2017-05-09

Ocata Anterior Cervical System

Applicant Kalitec Direct, LLC

K number K170342

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KWQ 2017-03-22

Butrex Lumbar Buttress Plating System

Applicant X-Spine Systems, Inc.

K number K170530

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KWQ 2017-02-17

Z-Span Plate System

Applicant Zavation, LLC

K number K162824

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KWQ 2017-02-16

Kepler I Cervical Plate System

Applicant Orbbo Surgical, LLC

K number K163602

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KWQ 2017-02-06

Altus Spine Cervical Plate System

Applicant Altus Partners, LLC

K number K163061

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KWQ 2017-01-05

LOSPA IS ACP System

Applicant Corentec Co., Ltd.

K number K161641

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KWQ 2016-12-22

Sphynx™

Applicant Eden Spine, LLC

K number K160982

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KWQ 2016-12-16

CETRA Anterior Cervical Plate System

Applicant Orthofix, Inc.

K number K162638

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KWQ 2016-12-08

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

Applicant Medicrea International SA

K number K162194

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KWQ 2016-11-28

AccuFit Lateral Plate System

Applicant Precision Spine, Inc.

K number K162211

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KWQ 2016-10-26

FortiBridge Anterior Cervical Plate System

Applicant Nanovis Spine, LLC

K number K162250

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KWQ 2016-10-07

Pyrenees Cervical Plate System

Applicant K2m, Inc.

K number K162664

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KWQ 2016-09-02

Tangis Anterior Cervical Plate

Applicant Nvision Biomedical Technologies, LLC

K number K161524

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KWQ 2016-08-23

ZION Anterior Cervical Fixation System

Applicant Astura Medical

K number K160702

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KWQ 2016-07-15

Belvedere™ Lateral Plating System

Applicant Neurostructures, Inc.

K number K153097

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KWQ 2016-07-01

Cure™ Anterior Cervical Plate (ACP) System

Applicant Meditech Spine, LLC

K number K160604

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KWQ 2016-04-27

Pyrenees Cervical Plate System

Applicant K2m

K number K153526

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KWQ 2016-04-26

White Pearl Preferred Angle Anterior Cervical Plate

Applicant Osseus Fusion Systems, LLC

K number K160522

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KWQ 2016-03-28

TRYPTIK2C-plate Anterior Cervical Plate System

Applicant Spineart

K number K153042

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KWQ 2016-03-22

Z-Span Plate System

Applicant Zavation, LLC

K number K160362

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KWQ 2016-02-10

Anterior Cervical Plate System

Applicant Osteomed Implantes, Ltda

K number K151553

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KWQ 2013-12-24

VELOX ANTERIOR CERVICAL PLATE SYSTEM

Applicant Spinecraft, LLC

K number K131521

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KWQ 2013-12-23

ASCOT

Applicant Backroads Consulting, Inc.

K number K132310

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KWQ 2013-12-19

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

Applicant Nexxt Spine, LLC

K number K133475

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KWQ 2013-12-05

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

Applicant Corelink, LLC

K number K132994

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KWQ 2013-11-27

ARCHON ANTERIOR CERVICAL PLATE SYSTEM

Applicant Nuvasive, Inc.

K number K131025

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KWQ 2013-11-09

CAYMAN MI PLATE SYSTEM

Applicant K2m, Inc.

K number K131533

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