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 |
|---|---|---|---|
| Sep 22, 2003 | K023983 | MODIFICATION TO HIGHGATE CURVED ROD SYSTEM Highgate Orthopaedics | KWQ |
| Sep 17, 2003 | K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM Spinal Concepts, Inc. | KWQ |
| Aug 11, 2003 | K032265 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWQ |
| Aug 8, 2003 | K031702 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM Howmedica Osteonics | KWQ |
| Jul 25, 2003 | K032059 | MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM Aesculap, Inc. | KWQ |
| Jul 2, 2003 | K031276 | SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM Synthes (Usa) | KWQ |
| Jun 27, 2003 | K021979 | SMISSON STABILIZATION SYSTEM Smisson-Cartledge | KWQ |
| May 28, 2003 | K030667 | ENCORE ANTERIOR SPINAL STAPLE SYSTEM Encore Medical L.P. | KWQ |
| Apr 24, 2003 | K030595 | BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. | KWQ |
| Apr 18, 2003 | K030866 | SYNTHES ANTERIOR CSLP SYSTEM Synthes (Usa) | KWQ |
| Mar 28, 2003 | K022965 | BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE Blackstone Medical, Inc. | KWQ |
| Mar 20, 2003 | K030500 | ORIA ZENITH Ortho Tec, LLC | KWQ |
| Mar 4, 2003 | K023377 | ORIA CERVICAL PLATES Ortho Tec, LLC | KWQ |
| Feb 26, 2003 | K030327 | ZEPHIR ANTERIOR CERVICAL SYSTEM Medtronic Sofamor Danek | KWQ |
| Jan 23, 2003 | K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. | KWQ |
| Dec 11, 2002 | K021039 | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM Depuyacromed | KWQ |
| Dec 6, 2002 | K022997 | SPECTRUM CERVICAL SPINAL SYSTEM Spinal Innovations, LLC | KWQ |
| Nov 19, 2002 | K022798 | CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS Corin USA | KWQ |
| Nov 13, 2002 | K022791 | SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM Synthes (Usa) | KWQ |
| Oct 25, 2002 | K021564 | INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | KWQ |
| Oct 18, 2002 | K023133 | MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. | KWQ |
| Sep 24, 2002 | K022344 | TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM Centerpulse Spine-Tech, Inc. | KWQ |
| Sep 17, 2002 | K021761 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek | KWQ |
| Aug 21, 2002 | K022605 | BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER Blackstone Medical, Inc. | KWQ |
| Aug 12, 2002 | K022419 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Ebi, L.P. | KWQ |
| Aug 6, 2002 | K022399 | BLACKSTONE SPINAL FIXATION SYSTEM SPACER Blackstone Medical, Inc. | KWQ |
| Jul 22, 2002 | K021461 | ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek | KWQ |
| May 23, 2002 | K020620 | BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. | KWQ |
| May 22, 2002 | K020600 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. | KWQ |
| May 13, 2002 | K021226 | MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM Medtronic Sofamor Danek | KWQ |
| Apr 22, 2002 | K020244 | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) Synthes Spine | KWQ |
| Apr 5, 2002 | K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM Ortho Development Corp. | KWQ |
| Mar 29, 2002 | K020650 | MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM Howmedica Osteonics Corp. | KWQ |
| Mar 12, 2002 | K012045 | HIGHGATE CURVED ROD SYSTEM Highgate Orthopaedics | KWQ |
| Feb 13, 2002 | K014107 | ENDIUS CERVICAL PLATE SYSTEM Endius, Inc. | KWQ |
| Feb 13, 2002 | K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. | KWQ |
| Jan 30, 2002 | K012184 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. | KWQ |
| Jan 29, 2002 | K013665 | PYRAMID ANTERIOR PLATE FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | KWQ |
| Jan 23, 2002 | K013558 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW Blackstone Medical, Inc. | KWQ |
| Jan 14, 2002 | K013439 | ANTERIOR CERVICAL PLATE SYSTEM Scien'Tx USA, Inc. | KWQ |
| Dec 19, 2001 | K013877 | CODMAN SLIM-LOC SYSTEM Codman & Shurtleff, Inc. | KWQ |
| Nov 27, 2001 | K012916 | FRONTIER ANTERIOR SCOLIOSIS SYSTEM Depuy Acromed, Inc. | KWQ |
| Nov 26, 2001 | K012881 | C3 ANTERIOR CERVICAL PLATE SYSTEM Spine Vision, Inc. | KWQ |
| Nov 16, 2001 | K011556 | MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM Aesculap, Inc. | KWQ |
| Aug 22, 2001 | K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM Sulzer Spine-Tech | KWQ |
| Jul 20, 2001 | K010911 | MACROPORE OS SPINAL SYSTEM Macropore Biosurgery, Inc. | KWQ |
| May 30, 2001 | K010639 | CONVERGENCE CERVICAL SPINAL SYSTEM Spinal Innovations, LLC | KWQ |
| May 16, 2001 | K010466 | TETHER ACFS Theken Surgical,Llc | KWQ |
| May 8, 2001 | K002824 | MACS MODULAR ANTERIOR CONSTRUCT SYSTEM Aesculap, Inc. | KWQ |
| Apr 16, 2001 | K010115 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM Howmedica Osteonics Corp. | KWQ |
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