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
May 16, 2007K063764SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM
Southern Spine, LLC
KWQ
May 9, 2007K070994EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
May 4, 2007K070681NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
Alphatec Spine, Inc.
KWQ
Apr 19, 2007K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
Globus Medical, Inc.
KWQ
Apr 16, 2007K070335SIMPLEX CERVICAL FIXATION SYSTEM
Pisharodi Surgicals, Inc.
KWQ
Apr 3, 2007K070273MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Mar 22, 2007K063430ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
Stryker Spine
KWQ
Mar 13, 2007K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
Life Spine
KWQ
Feb 23, 2007K063100ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
Medtronic Sofamor Danek, Inc.
KWQ
Feb 14, 2007K063544MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
K2m, Inc.
KWQ
Jan 18, 2007K062590NUVASIVE ACP4 SYSTEM
Nuvasive, Inc.
KWQ
Dec 19, 2006K062836CITADEL ANTERIOR LUMBAR PLATE SYSTEM
Globus Medical, Inc.
KWQ
Dec 4, 2006K062371PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
Alphaspine, Inc.
KWQ
Nov 16, 2006K062643KINETIC ANTERIOR CERVICAL PLATE
Life Spine
KWQ
Nov 15, 2006K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
U&I Corp., KR
KWQ
Nov 14, 2006K063158SYNTHES ANTEGRA SYSTEM
Synthes Spine Co.Lp
KWQ
Oct 19, 2006K062831MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
Life Spine
KWQ
Oct 5, 2006K062686UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
Advanced Spine Technology, Inc.
KWQ
Sep 6, 2006K062407GATEWAY THORACOLUMBAR PLATE SYSTEM
Globus Medical, Inc.
KWQ
Aug 30, 2006K061353TRINICA ANTERIOR LUMBAR PLATE SYSTEM
Zimmer Spine, Inc.
KWQ
Aug 18, 2006K062310REFLEX HYBRID ACP SYSTEM
Stryker Spine
KWQ
Aug 16, 2006K062110VERTEBRON SCP CERVICAL PLATE SYSTEM
Vertebron, Inc.
KWQ
Aug 10, 2006K061789LATERAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Jul 26, 2006K061482ALTES BUTTRESS PLATING SYSTEM
Altiva Corp.
KWQ
Jul 24, 2006K061229UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
Blackstone Medical, Inc.
KWQ
Jun 30, 2006K061147OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
Innovasis, Inc.
KWQ
May 25, 2006K061274VENTURE ANTERIOR CERVICAL PLATE SYSTEM
Medtronic Sofamor Danek
KWQ
May 15, 2006K060442PYRENEES CERVICAL PLATE SYSTEM
K2m, LLC
KWQ
Apr 18, 2006K060025SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
Spinal USA
KWQ
Mar 13, 2006K060491QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
Quantum Orthopedics, Inc.
KWQ
Mar 6, 2006K060379EBI ANTERIOR CERVICAL PLATE SYSTEM
Ebi, L.P.
KWQ
Feb 17, 2006K053581NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
Nuvasive, Inc.
KWQ
Feb 3, 2006K052546AEGIS ANTERIOR LUMBAR PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Nov 16, 2005K053053PACP SYSTEM
Pioneer Surgical Technology
KWQ
Nov 10, 2005K052763STELLA CERVICAL PLATE
Scient'X
KWQ
Oct 21, 2005K052292SPIDER CERVICAL PLATING (SCP) SYSTEM
X-Spine Systems, Inc.
KWQ
Oct 17, 2005K051815MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
Vertebron, Inc.
KWQ
Oct 17, 2005K051531TECTONIC CERVICAL PLATE SYSTEM
K2m, LLC
KWQ
Oct 13, 2005K052552HYBRID ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Sep 9, 2005K051665SYNTHES VECTRA-T SYSTEM
Synthes Spine
KWQ
Aug 29, 2005K052072THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
Abbott Spine, Inc.
KWQ
Aug 4, 2005K051971OPTIMA SPINAL SYSTEM
U&I Corp., KR
KWQ
Jul 13, 2005K051764T-PLATE ANTERIOR FIXATION SYSTEM
Esm Technologies
KWQ
Jun 14, 2005K050965TRANS1 AXIALIF SYSTEM
Trans1 Incorporated
KWQ
Jun 14, 2005K043548BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
Blackstone Medical, Inc.
KWQ
May 12, 2005K051039BASIS SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWQ
May 11, 2005K050892HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
Blackstone Medical, Inc.
KWQ
May 4, 2005K050813ABC 2 SCREW
Aesculap, Inc.
KWQ
Apr 21, 2005K050588VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
Innovative Spinal Design, LLC
KWQ
Apr 11, 2005K050804MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
Aesculap, Inc.
KWQ

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