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)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2011 | K103491 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM A Johnson & Johnson Company | KWQ |
| Feb 10, 2011 | K103137 | VENUS ANTERIOR CERVICAL PLATE Verticor, Ltd. | KWQ |
| Feb 4, 2011 | K101353 | GOLDEN GATE ANTERIOR PLATE SYSTEM Ulrich GmbH & Co. KG | KWQ |
| Feb 2, 2011 | K103393 | POLARIS SPINAL SYSTEM Biomet Spine | KWQ |
| Jan 14, 2011 | K103068 | KING COBRA ANTERIOR CERVICAL PLATE Eminent Spine | KWQ |
| Jan 12, 2011 | K103070 | GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + G Surgical Co., Ltd., TH | KWQ |
| Nov 5, 2010 | K102820 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Alphatec Spine, Inc. | KWQ |
| Oct 14, 2010 | K101848 | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM Spinal Elements, Inc. | KWQ |
| Sep 29, 2010 | K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM Ldr Spine USA | KWQ |
| Sep 2, 2010 | K100243 | QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC | KWQ |
| Jul 21, 2010 | K101255 | ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM Alphatec Spine, Inc. | KWQ |
| Jun 4, 2010 | K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES Pioneer Surgical Technology | KWQ |
| May 21, 2010 | K092695 | TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM Transcorp, Inc. | KWQ |
| May 21, 2010 | K090861 | MAMBO, MODEL CS 18XX-XX Ulrich GmbH & Co. KG | KWQ |
| May 19, 2010 | K101151 | REGENT ANTERIOR CERVICAL PLATE Custom Spine | KWQ |
| May 13, 2010 | K100265 | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM Amendia, Inc. | KWQ |
| May 4, 2010 | K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES Blackstone Medical, Inc. | KWQ |
| Apr 7, 2010 | K100215 | ARCHIMED REMEDY CERVICAL PLATE Archimed, Inc. | KWQ |
| Apr 7, 2010 | K092765 | LANX ANTERIOR PLATING SYSTEM Lanx, Inc. | KWQ |
| Mar 26, 2010 | K093776 | INDUS ANTERIOR CERVICAL PLATE SYSTEM Spinefrontier, Inc. | KWQ |
| Mar 11, 2010 | K092474 | PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2m, Inc. | KWQ |
| Feb 19, 2010 | K093804 | NUVASIVE HELIX REVOLUTION ACP SYSTEM Nuvasive, Inc. | KWQ |
| Feb 12, 2010 | K100061 | CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX K2m, Inc. | KWQ |
| Feb 4, 2010 | K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Feb 4, 2010 | K092531 | SPINE360 ANTERIOR CERVICAL PLATE SYSTEM Spine360 | KWQ |
| Jan 22, 2010 | K092360 | ACP4 SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. | KWQ |
| Jan 21, 2010 | K092124 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II Trans1 Incorporated | KWQ |
| Jan 19, 2010 | K093200 | LIFE SPINE LUMBAR PLATE SYSTEM Life Spine | KWQ |
| Jan 19, 2010 | K091936 | BLADE ANTERIOR CERVICAL PLATE SYSTEM Nexxt Medical, Inc. | KWQ |
| Dec 22, 2009 | K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM Choicespine, LP | KWQ |
| Nov 17, 2009 | K092659 | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 Spinal USA | KWQ |
| Nov 16, 2009 | K092146 | XTEND ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. | KWQ |
| Oct 23, 2009 | K090751 | COMET ANTERIOR CERVICAL PLATE SYSTEM Apollo Spine, Inc. | KWQ |
| Oct 6, 2009 | K092070 | INTERPLATE C Rsb Spine, LLC | KWQ |
| Aug 17, 2009 | K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE Custom Spine, Inc. | KWQ |
| Aug 13, 2009 | K092108 | TRUSS THORACOLUMBAR PLATE SYSTEM Globus Medical, Inc. | KWQ |
| Aug 5, 2009 | K091396 | CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM Cardo Medical Corp. | KWQ |
| Jul 10, 2009 | K091159 | SYNTHES ORACLE PLATE Synthes Spine | KWQ |
| Jul 9, 2009 | K091044 | SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM Spinal USA | KWQ |
| Jun 4, 2009 | K091253 | THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2m, Inc. | KWQ |
| Jun 1, 2009 | K090415 | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM Eminent Spine | KWQ |
| May 8, 2009 | K091071 | NUVASIVE LATERAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Apr 28, 2009 | K090222 | PIONEER LUMBAR PLATE SYSTEM Pioneer Surgical Technology | KWQ |
| Apr 7, 2009 | K090316 | MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM Lanx, Inc. | KWQ |
| Apr 2, 2009 | K081770 | BLACK WIDOW ANTERIOR BUTTRESS PLATE Omni Surgical, L.P. | KWQ |
| Mar 26, 2009 | K083020 | STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM Stryker Corp. | KWQ |
| Mar 25, 2009 | K083562 | STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM Stryker Corp. | KWQ |
| Mar 20, 2009 | K083341 | NUVASIVE HELIX-T ACP SYSTEM Nuvasive, Inc. | KWQ |
| Feb 25, 2009 | K083663 | PACP Pioneer Surgical Technology | KWQ |
| Feb 2, 2009 | K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM Seaspine, Inc. | KWQ |
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