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
Jan 29, 2009K081548ANTERIOR BUTTRESS PLATE
Scient'X USA, Inc.
KWQ
Jan 27, 2009K082504APOLLO ANTERIOR CERVICAL PLATE SYSTEM
Apollo Spine, Inc.
KWQ
Nov 19, 2008K081380THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K2m, Inc.
KWQ
Nov 13, 2008K082187BIOMET ANTERIOR LUMBAR PLATE
Ebi, L.P.
KWQ
Oct 31, 2008K082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
Spine Smith Partners L.P.
KWQ
Sep 26, 2008K082037SEEPLATE CERVICAL PLATE SYSTEM
Amedica Corp.
KWQ
Sep 24, 2008K082070NUVASIVE LATERAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Sep 10, 2008K082273UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Sep 2, 2008K081568ANTEGRA-T
Synthes Spine Co.Lp
KWQ
Aug 15, 2008K081038ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Medtronic Sofamor Danek
KWQ
Jul 14, 2008K081418SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
Spinal Elements, Inc.
KWQ
Jul 14, 2008K081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
Spine Smith Partners L.P.
KWQ
Jul 3, 2008K081567VERTEBRON SSP CERVICAL PLATING SYSTEM
Vertebron, Inc.
KWQ
Jul 3, 2008K081391VIP ANTERIOR CERVICAL PLATE SYSTEM
Globus Medical, Inc.
KWQ
Jul 3, 2008K073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
Sanacor
KWQ
Jun 9, 2008K080773THOR ANTERIOR PLATING SYSTEM
Stryker Spine
KWQ
Jun 3, 2008K073708FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Precision Surgery , Ltd.
KWQ
May 23, 2008K080020ARCOFIX
Synthes Spine Co.Lp
KWQ
May 2, 2008K080646C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
Biomet Spine
KWQ
Apr 30, 2008K080429MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWQ
Apr 28, 2008K073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
Trans1 Incorporated
KWQ
Apr 25, 2008K080690MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
Theken Spine, LLC
KWQ
Apr 23, 2008K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
Signus Medizintechnik GmbH
KWQ
Apr 2, 2008K080191EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Mar 24, 2008K080302CAYMAN BUTTRESS PLATE SYSTEM
K2m, Inc.
KWQ
Feb 20, 2008K073232INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
Spinefrontier, Inc.
KWQ
Feb 13, 2008K073437THOR ANTERIOR PLATING SYSTEM
Stryker Spine
KWQ
Feb 13, 2008K073349RELIANCE BUTTRESS WASHER SYSTEM
Reliance Medical Systems, LLC
KWQ
Jan 31, 2008K073530ACCIN ANTERIOR CERVICAL PLATE SYSTEM
Accelerated Innovation, LLC
KWQ
Jan 29, 2008K073275NUVASIVE HELIX MINI ACP SYSTEM
Nuvasive, Inc.
KWQ
Jan 28, 2008K072943BUTREX BUTTRESS PLATING SYSTEM
X-Spine Systems, Inc.
KWQ
Jan 11, 2008K073514TRANS1 AXIAL FIXATON SYSTEM
Trans1 Incorporated
KWQ
Jan 10, 2008K072703PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
Pioneer Surgical Technology
KWQ
Jan 9, 2008K073479KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
Life Spine
KWQ
Dec 28, 2007K071905POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Lanx, LLC
KWQ
Dec 26, 2007K072231THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
Esm Technologies, LLC
KWQ
Dec 21, 2007K072407BODYFORM THORACIC FIXATION SYSTEM
Theken Spine, LLC
KWQ
Nov 30, 2007K071667SYNTHES VECTRA-ONE SYSTEM
Synthes Spine
KWQ
Nov 28, 2007K072650IST ANTERIOR CERVICAL PLATE SYSTEM
Innovative Spinal Technologies, Inc.
KWQ
Nov 7, 2007K071151TENSION BAND ANTERIOR SPINAL SYSTEM
Spinal Instrumentation Simplification Systems, LLC
KWQ
Nov 1, 2007K071416PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWQ
Oct 29, 2007K071990VALEO CERVICAL PLATE SYSTEM
Amedica Corp.
KWQ
Oct 19, 2007K072339NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
Nuvasive, Inc.
KWQ
Oct 5, 2007K072546SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Sep 19, 2007K070922MODIFICATION TO SPINAL USA VBR SYSTEM
Spinal USA
KWQ
Aug 8, 2007K071329NUVASIVE HELIX ACP SYSTEM
Nuvasive, Inc.
KWQ
Aug 3, 2007K072040C-JAWS CERVICAL COMPRESSIVE MINI FRAME
Medicrea Technologies
KWQ
Jul 31, 2007K070148GRAFT CONTAINMENT DEVICE
Nuvasive, Inc.
KWQ
Jun 11, 2007K070891ALTIVA CLASSIC ACP SYSTEM
Altiva Corp.
KWQ
May 30, 2007K061385OSSTAPLE, OSSPLATE, OSSFORCE
Biomedical Enterprises, Inc.
KWQ

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