Panels › Orthopedic › Product code MQP · Class 2
Spinal Vertebral Body Replacement Device
Regulation 888.3060
3510(k)s in 12 months (279 all time)
0recalls in 12 months (46 all time)
42recalls that name a 510(k)
Top companies in MQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 36 | 0 |
| Synthes (USA) Products LLC | 0 | 15 |
| Synthes USA (HQ), Inc. | 0 | 12 |
| Globus Medical, Inc. | 11 | 0 |
| Interpore Cross Intl. | 10 | 0 |
| Spine Wave, Inc. | 10 | 0 |
| Depuyacromed | 8 | 0 |
| Ebi, L.P. | 6 | 2 |
| Implex Corp. | 8 | 0 |
| K2m | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2013 | K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE Medtronic Sofamor Danek, Inc. | MQP |
| Sep 19, 2012 | K122622 | ENDURAMESH Lucero Medical, LLC | MQP |
| Aug 29, 2012 | K121889 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Aug 17, 2012 | K121176 | STGC Cardinal Spine, LLC | MQP |
| Jul 3, 2012 | K121107 | FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) Globus Medical, Inc. | MQP |
| Apr 5, 2012 | K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM Choicespine, LP | MQP |
| Jan 27, 2012 | K111294 | SANTORINI SPINAL SYSTEM K2m, Inc. | MQP |
| Jan 26, 2012 | K112429 | GIZA(R) VERTEBRAL BODY REPLACEMENT Eden Spine, LLC | MQP |
| Dec 13, 2011 | K111418 | STAXX(R) XD SYSTEM Spine Wave, Inc. | MQP |
| Oct 20, 2011 | K103320 | SYNTHES XRL Synthes Spine Co.Lp | MQP |
| Oct 12, 2011 | K110153 | SFC VERTEBRAL BODY REPLACEMENT Konigsee Implantate GmbH | MQP |
| Oct 7, 2011 | K112756 | FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS Globus Medical, Inc. | MQP |
| Aug 19, 2011 | K102315 | STAXX XDL SYSTEM Spine Wave, Inc. | MQP |
| Jul 21, 2011 | K101886 | DSC/ALF SPINAL SYSTEM Sintea Plastek, LLC | MQP |
| Jul 19, 2011 | K111469 | STAXXSD SYSTEM Spine Wave, Inc. | MQP |
| Jun 15, 2011 | K110864 | BIOSPINE VBR SYSTEM Aesculap Implant Systems, LLC | MQP |
| Nov 30, 2010 | K102682 | STAXX(R) XD SYSTEM Spine Wave, Inc. | MQP |
| Oct 21, 2010 | K100976 | T2 XVBR 1.5 SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MQP |
| Sep 10, 2010 | K101288 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Apr 26, 2010 | K093207 | ENDURAMESH, MODEL 762.XXX Lucero Medical, LLC | MQP |
| Mar 4, 2010 | K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET Zimmer Trabecular Metal Technology | MQP |
| Mar 4, 2010 | K083186 | AESCULAP HYDROLIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Dec 23, 2009 | K091426 | CERVICORE CORPECTOMY CAGE Verticor, Ltd. | MQP |
| Nov 2, 2009 | K091743 | SEC VBR Innvotec Surgical, Inc. | MQP |
| Oct 15, 2009 | K092336 | C-THRU SPINAL SYSTEM Ebi, L.P. | MQP |
| Oct 5, 2009 | K090841 | ADDPLUS Ulrich GmbH & Co. KG | MQP |
| Sep 25, 2009 | K091946 | VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX Stryker Spine | MQP |
| Sep 21, 2009 | K091883 | T2 SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MQP |
| Sep 4, 2009 | K091406 | ATLAS SPINE SPACER Atlas Spine, LLC | MQP |
| Sep 3, 2009 | K090315 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Apr 27, 2009 | K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM Nuvasive, Inc. | MQP |
| Feb 12, 2009 | K083857 | LDR SPINE ROI-C IMPLANT Ldr Spine USA | MQP |
| Jan 9, 2009 | K082466 | XYCOR SPINAL IMPLANT Vertebration,Inc | MQP |
| Aug 27, 2008 | K082112 | T2 XVBR SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Jul 2, 2008 | K081383 | RELIANCE VBS SYSTEM Reliance Medical Systems, LLC | MQP |
| Jul 2, 2008 | K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM Spine Smith Partners L.P. | MQP |
| Jun 30, 2008 | K081564 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION Creaspine | MQP |
| Jun 24, 2008 | K072326 | OSTAPEK VBR SYSTEM Co-Ligne AG | MQP |
| Jun 10, 2008 | K081332 | ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM Signus Medizintechnik GmbH | MQP |
| May 29, 2008 | K080860 | CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM Creaspine | MQP |
| May 29, 2008 | K080728 | LDR SPINE ROI-C IMPLANT Ldr Spine USA | MQP |
| May 21, 2008 | K080699 | NOVEL SPINAL SPACER SYSTEM Alphatec Spine, Inc. | MQP |
| May 7, 2008 | K080569 | LDR SPINE ROI-T IMPLANT Ldr Spine USA | MQP |
| May 1, 2008 | K080568 | X-MESH EXPANDABLE CAGE SYSTEM Depuy Spine, Inc. | MQP |
| Apr 7, 2008 | K080572 | LDR SPINE ROI-A IMPLANT Ldr Spine USA | MQP |
| Mar 24, 2008 | K073502 | VERTEBRON VBR SYSTEM Vertebron, Inc. | MQP |
| Mar 10, 2008 | K080349 | KIMBA MINI Signus Medizintechnik GmbH | MQP |
| Jan 25, 2008 | K073649 | BENGAL STACKABLE CAGE SYSTEM Depuy Spine, Inc. | MQP |
| Jan 24, 2008 | K080024 | ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 K2m, Inc. | MQP |
| Jan 9, 2008 | K073505 | MODIFICATION TO VALEO VBR Amedica Corp. | MQP |
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