ClearanceBrief
Panels › Orthopedic › Product code KWQ · Class 2

Appliance, Fixation, Spinal Intervertebral Body

Regulation 888.3060

11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
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Top companies in KWQ

Company510(k)sRecalls
Stryker Spine638
Alphatec Spine, Inc.932
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)041
Zimmer, Inc.137
Medtronic Sofamor Danek298
Nuvasive, Inc.210
K2m200
Depuy Spine, Inc.108
Blackstone Medical, Inc.133
Globus Medical, Inc.150
Decided510(k)Device and applicantCode
Jul 11, 2013K131520NEXUS ANTERIOR CERVICAL PLATE SYSTEM
Core-Nexus
KWQ
Jun 5, 2013K130427PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
Pioneer Surgical Technology, Inc.
KWQ
Jun 4, 2013K130640ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWQ
May 7, 2013K130825AZURE ANTERIOR CERVICAL PLATE SYSTEM
Orthofix, Inc.
KWQ
Apr 29, 2013K130202IRIS ANTERIOR CERVICAL PLATE
Life Spine, Inc.
KWQ
Apr 25, 2013K130030ZAVATION CERVICAL PLATE SYSTEM
Zavation, LLC
KWQ
Feb 1, 2013K123578ANTERIOR CERVICAL PLATE SYSTEM
Weigao Orthopaedic Device Co., Ltd., CN
KWQ
Feb 1, 2013K122081NUVASIVE LONG LATERAL SPINAL SYSTEM
Nuvasive, Inc.
KWQ
Dec 28, 2012K123167DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
Medos International SARL
KWQ
Dec 14, 2012K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
Corelink, LLC
KWQ
Dec 7, 2012K122733V2F ANTERIOR FIXATION SYSTEM
Zimmer Spine, Inc.
KWQ
Nov 19, 2012K121791ZOU ANTERIOR LUMBAR PLATE SYSTEM
Corelink, LLC
KWQ
Oct 31, 2012K121862REX ANTERIOR CERVICAL PLATE SYSTEM
Dio Medical Co., Ltd.
KWQ
Oct 23, 2012K121815NUVASIVE SAGE LATERAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Oct 15, 2012K122497ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
Medical Design, LLC
KWQ
Oct 11, 2012K122910ARCHON ANTERIOR CERVICAL PLATE SYSTE,
Nu Vasive, Incorporated
KWQ
Sep 13, 2012K121078VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
Accel Spine
KWQ
Sep 11, 2012K121801QUINTEX CERVICAL PLATING SYSTEM
Aesculap Implant Systems, LLC
KWQ
Sep 5, 2012K122216RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
Reliance Medical Systems, LLC
KWQ
Jul 20, 2012K121658ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
Orthofix, Inc.
KWQ
Jul 18, 2012K121323MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
Medicrea International, FR
KWQ
Jul 16, 2012K121837NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
Nuvasive, Inc.
KWQ
Jul 11, 2012K112748SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
Spinal USA, LLC
KWQ
Jul 3, 2012K121060SPINE FRONTIER INDUS ACP SYSTEM
Spinefrontier, Inc.
KWQ
Jun 27, 2012K121049UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
Globus Medical, Inc.
KWQ
Jun 20, 2012K112809BLUE MOUNTAIN CERVICAL PLATE
Qualgenix, LLC
KWQ
May 23, 2012K120515TEMPUS CERVICAL PLATE SYSTEM
Neurostructures, LLC
KWQ
May 7, 2012K120724PIONEER LATERAL PLATE SYSTEM
Pioneer Surgical Technology, Inc.
KWQ
Apr 13, 2012K120092PLYMOUTH THORACOLUMBAR PLATE SYSTEM
Globus Medical, Inc.
KWQ
Apr 6, 2012K113170CERVICAL PLATE
Eisertech, LLC
KWQ
Feb 24, 2012K112861SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
Sintea Plustek, LLC
KWQ
Jan 25, 2012K112206CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
Seaspine, Inc.
KWQ
Jan 20, 2012K113509LEXUS ANTERIOR CERVICAL PLATE SYSTEM
L&K BIOMED Co., Ltd., KR
KWQ
Jan 17, 2012K113329K2M, PYRENEES CERVICAL PLATE SYSTEM
K2m, Inc.
KWQ
Dec 9, 2011K111132GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
Genesys Spine
KWQ
Dec 8, 2011K112533ZAVATION CERVICAL PLATE SYSTEM
Zavation, LLC
KWQ
Nov 21, 2011K112724DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
Medos International SARL
KWQ
Oct 27, 2011K111796INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
Zimmer Spine, Inc.
KWQ
Aug 24, 2011K111528PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
Pioneer Surgical Technology, Inc.
KWQ
Aug 23, 2011K102406PASS ANTERIOR SPINAL SYSTEM
Medicrea Technologies
KWQ
Aug 17, 2011K111135PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K2m, Inc.
KWQ
Jul 25, 2011K110990GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
Gold Standard Orthopedics, LLC
KWQ
Jul 22, 2011K111866NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
Nuvasive, Inc.
KWQ
Jun 20, 2011K111410NUVASIVE LONG LATERAL SPINAL SYSTEM
Nuvasive, Inc.
KWQ
Jun 1, 2011K103423MIS ANTERIOR CERVICAL PLATING SYSTEM
Life Spine
KWQ
Mar 15, 2011K103505ALTUM ANTERIOR CERVICAL PLATE
Spinecraft, LLC
KWQ
Mar 14, 2011K102334TRANS1 AXIALIF PLUS
Trans1 Incorporated
KWQ
Mar 3, 2011K103750NUVASIVE TRAVERSE PLATE SYSTEM
Nuvasive, Inc.
KWQ
Feb 15, 2011K103838FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Precision Surgery , Ltd.
KWQ
Feb 15, 2011K103819PSL ANTERIOR CERVICAL PLATE SYSTEM
Precision Surgery , Ltd.
KWQ

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