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 |
|---|---|---|---|
| Jun 8, 2006 | K061016 | EBI ESL PEEK-OPTIMA SPINE SYSTEM Ebi, L.P. | MQP |
| Jun 8, 2006 | K060916 | ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. Spinal Edge, LLC | MQP |
| May 25, 2006 | K060506 | STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM Stryker Spine | MQP |
| May 10, 2006 | K060665 | XPAND RADIOLUCENT CORPECTOMY SPACER Globus Medical, Inc. | MQP |
| Apr 27, 2006 | K052670 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Apr 14, 2006 | K060719 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Apr 12, 2006 | K052641 | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT Quantum Orthopedics, Inc. | MQP |
| Feb 24, 2006 | K060350 | CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM Blackstone Medical, Inc. | MQP |
| Feb 17, 2006 | K051525 | ARX SPINAL SYSTEM Amedica Corp. | MQP |
| Feb 13, 2006 | K053508 | SYNFIX-LR Synthes Spine Co.Lp | MQP |
| Jan 19, 2006 | K053292 | DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS Scient'X USA, Inc. | MQP |
| Dec 21, 2005 | K052170 | SEASPINE VBR SYSTEM Seaspine, Inc. | MQP |
| Dec 16, 2005 | K051781 | GRAFTCAGE TLX Osteotech, Inc. | MQP |
| Dec 12, 2005 | K052210 | NUVASIVE COROENT EXTENSURE SYSTEM Nuvasive, Inc. | MQP |
| Dec 1, 2005 | K053080 | GRAFTCAGE ACX Osteotech, Inc. | MQP |
| Nov 16, 2005 | K052950 | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM Zimmer Trabecular | MQP |
| Nov 16, 2005 | K052931 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Nov 4, 2005 | K051205 | STRYKER SPINE AVS ASL PEEK SPACER Stryker Spine | MQP |
| Nov 3, 2005 | K052533 | KIMBA SPINAL IMPLANT Signus Medizintechnik GmbH | MQP |
| Oct 21, 2005 | K052746 | CONCORDE VBR SPINAL SYSTEM Depuy Spine, Inc. | MQP |
| Oct 7, 2005 | K052384 | LANX VBR SYSTEM Lanx, LLC | MQP |
| Oct 7, 2005 | K052261 | MODIFICATION TO: VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MQP |
| Oct 7, 2005 | K050997 | EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE Flexuspine, Inc. | MQP |
| Sep 23, 2005 | K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT Implex Corp. | MQP |
| Aug 16, 2005 | K052096 | NUBIC SPINAL IMPLANT Signus Medical, LLC | MQP |
| Jul 27, 2005 | K051454 | ALEUTIAN SPACER SYSTEM K2m, LLC | MQP |
| Jul 13, 2005 | K051659 | SEMIAL SPINAL IMPLANT Signus Medizintechnik GmbH | MQP |
| Jul 7, 2005 | K050449 | QUANTUM VERTEBRAL BODY REPLACEMENT Quantum Orthopedics, Inc. | MQP |
| Jun 30, 2005 | K043479 | MC+ PARTIAL VBR Ldr Spine USA | MQP |
| Jun 29, 2005 | K051027 | STALIF TT Surgicraft , Ltd. | MQP |
| Jun 29, 2005 | K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) Ldr Spine USA | MQP |
| Jun 17, 2005 | K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 Implex Corp. | MQP |
| Jun 14, 2005 | K051246 | CONSTRUX MINI PEEK VBR SYSTEM Blackstone Medical, Inc. | MQP |
| Jun 9, 2005 | K051105 | BASIS VERTEBRAL BODY SPACER Medtronic Sofamor Danek | MQP |
| May 27, 2005 | K050861 | PEEK CAS Interpore Cross Intl. | MQP |
| May 27, 2005 | K050348 | CO VERTEBRAL BODY REPLACEMENT Scient'X | MQP |
| May 26, 2005 | K050850 | XPAND CORPECTOMY SPACER Globus Medical, Inc. | MQP |
| May 19, 2005 | K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE Spinal Concepts, Inc. | MQP |
| May 17, 2005 | K050058 | THEKEN REVEAL VBR SYSTEM Theken Surgical,Llc | MQP |
| Apr 18, 2005 | K050553 | NOVEL VBR SPINAL SYSTEM Alphatec/Nexmed | MQP |
| Apr 11, 2005 | K050624 | STRYKER SPINE AVS PL PEEK SPACER Stryker Spine | MQP |
| Feb 18, 2005 | K042600 | STANSION MATRIX Spineworks, LLC | MQP |
| Feb 11, 2005 | K042571 | STRYKER SPINE AVS TL PEEK SPACER Stryker Spine | MQP |
| Feb 7, 2005 | K043405 | NUVASIVE COROENT SYSTEM Nuvasive, Inc. | MQP |
| Feb 7, 2005 | K043316 | RABEA SPINAL IMPLANT Signus Medizintechnik GmbH | MQP |
| Feb 7, 2005 | K041798 | ATALIA TITANIUM SURGICAL MESH Us Spinal Technologies, LLC | MQP |
| Jan 21, 2005 | K043206 | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) Pioneer Surgical Technology | MQP |
| Jan 7, 2005 | K043566 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Dec 29, 2004 | K043561 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Dec 29, 2004 | K042714 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 Spine Next America Corporation | MQP |
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