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
Feb 14, 2011K103491SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
A Johnson & Johnson Company
KWQ
Feb 10, 2011K103137VENUS ANTERIOR CERVICAL PLATE
Verticor, Ltd.
KWQ
Feb 4, 2011K101353GOLDEN GATE ANTERIOR PLATE SYSTEM
Ulrich GmbH & Co. KG
KWQ
Feb 2, 2011K103393POLARIS SPINAL SYSTEM
Biomet Spine
KWQ
Jan 14, 2011K103068KING COBRA ANTERIOR CERVICAL PLATE
Eminent Spine
KWQ
Jan 12, 2011K103070GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
G Surgical Co., Ltd., TH
KWQ
Nov 5, 2010K102820APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Alphatec Spine, Inc.
KWQ
Oct 14, 2010K101848SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
Spinal Elements, Inc.
KWQ
Sep 29, 2010K102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
Ldr Spine USA
KWQ
Sep 2, 2010K100243QUINTEX CERVICAL PLATING SYSTEM
Aesculap Implant Systems, LLC
KWQ
Jul 21, 2010K101255ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
Alphatec Spine, Inc.
KWQ
Jun 4, 2010K100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
Pioneer Surgical Technology
KWQ
May 21, 2010K092695TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM
Transcorp, Inc.
KWQ
May 21, 2010K090861MAMBO, MODEL CS 18XX-XX
Ulrich GmbH & Co. KG
KWQ
May 19, 2010K101151REGENT ANTERIOR CERVICAL PLATE
Custom Spine
KWQ
May 13, 2010K100265DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
Amendia, Inc.
KWQ
May 4, 2010K100614HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
Blackstone Medical, Inc.
KWQ
Apr 7, 2010K100215ARCHIMED REMEDY CERVICAL PLATE
Archimed, Inc.
KWQ
Apr 7, 2010K092765LANX ANTERIOR PLATING SYSTEM
Lanx, Inc.
KWQ
Mar 26, 2010K093776INDUS ANTERIOR CERVICAL PLATE SYSTEM
Spinefrontier, Inc.
KWQ
Mar 11, 2010K092474PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
K2m, Inc.
KWQ
Feb 19, 2010K093804NUVASIVE HELIX REVOLUTION ACP SYSTEM
Nuvasive, Inc.
KWQ
Feb 12, 2010K100061CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K2m, Inc.
KWQ
Feb 4, 2010K100070UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Depuy Spine, Inc.
KWQ
Feb 4, 2010K092531SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
Spine360
KWQ
Jan 22, 2010K092360ACP4 SPINAL IMPLANT SYSTEM
X-Spine Systems, Inc.
KWQ
Jan 21, 2010K092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
Trans1 Incorporated
KWQ
Jan 19, 2010K093200LIFE SPINE LUMBAR PLATE SYSTEM
Life Spine
KWQ
Jan 19, 2010K091936BLADE ANTERIOR CERVICAL PLATE SYSTEM
Nexxt Medical, Inc.
KWQ
Dec 22, 2009K091926CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
Choicespine, LP
KWQ
Nov 17, 2009K092659SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
Spinal USA
KWQ
Nov 16, 2009K092146XTEND ANTERIOR CERVICAL PLATE SYSTEM
Globus Medical, Inc.
KWQ
Oct 23, 2009K090751COMET ANTERIOR CERVICAL PLATE SYSTEM
Apollo Spine, Inc.
KWQ
Oct 6, 2009K092070INTERPLATE C
Rsb Spine, LLC
KWQ
Aug 17, 2009K091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
Custom Spine, Inc.
KWQ
Aug 13, 2009K092108TRUSS THORACOLUMBAR PLATE SYSTEM
Globus Medical, Inc.
KWQ
Aug 5, 2009K091396CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
Cardo Medical Corp.
KWQ
Jul 10, 2009K091159SYNTHES ORACLE PLATE
Synthes Spine
KWQ
Jul 9, 2009K091044SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
Spinal USA
KWQ
Jun 4, 2009K091253THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
K2m, Inc.
KWQ
Jun 1, 2009K090415EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
Eminent Spine
KWQ
May 8, 2009K091071NUVASIVE LATERAL PLATE SYSTEM
Nuvasive, Inc.
KWQ
Apr 28, 2009K090222PIONEER LUMBAR PLATE SYSTEM
Pioneer Surgical Technology
KWQ
Apr 7, 2009K090316MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
Lanx, Inc.
KWQ
Apr 2, 2009K081770BLACK WIDOW ANTERIOR BUTTRESS PLATE
Omni Surgical, L.P.
KWQ
Mar 26, 2009K083020STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
Stryker Corp.
KWQ
Mar 25, 2009K083562STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
Stryker Corp.
KWQ
Mar 20, 2009K083341NUVASIVE HELIX-T ACP SYSTEM
Nuvasive, Inc.
KWQ
Feb 25, 2009K083663PACP
Pioneer Surgical Technology
KWQ
Feb 2, 2009K083338CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
Seaspine, Inc.
KWQ

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