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 |
|---|---|---|---|
| Dec 29, 2004 | K042713 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 Spine Next America Corporation | MQP |
| Dec 29, 2004 | K041407 | TITANIUM MESH IMPLANT Interpore Cross Intl. | MQP |
| Dec 28, 2004 | K042930 | SPACEVISION CAGE SYSTEM Spine Vision, Inc. | MQP |
| Oct 27, 2004 | K042268 | EBI CAS SPINE SPACER SYSTEM Ebi, L.P. | MQP |
| Oct 7, 2004 | K042201 | NOVEL VBR SPINAL SYSTEM Alphatec/Nexmed | MQP |
| Oct 1, 2004 | K041389 | SYNTHES CONTOURED SYNMESH SPACER Synthes Spine | MQP |
| Sep 23, 2004 | K041722 | MODIFICATION TO VBR SPINAL SYSTEM Depuy Spine, Inc. | MQP |
| Sep 8, 2004 | K041617 | STALIF TT Surgicraft , Ltd. | MQP |
| Aug 27, 2004 | K040928 | EXPANDABLE PEEK VBR IMPLANT Interpore Cross Intl. | MQP |
| Aug 17, 2004 | K041939 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS Blackstone Medical, Inc. | MQP |
| Aug 10, 2004 | K041888 | CURVED PEEK TETRIS SPINAL IMPLANT Signus Medizintechnik GmbH | MQP |
| Aug 9, 2004 | K041197 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Aug 5, 2004 | K040731 | STRYKER SPINE VERTEBRAL SPACER Stryker Spine | MQP |
| Jul 7, 2004 | K033926 | HOURGLASS VERTEBRAL BODY SPACER Medtronic Sofamor Danek | MQP |
| Jul 1, 2004 | K041556 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Jun 24, 2004 | K041452 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| May 27, 2004 | K033663 | SPINAL CONCEPTS INC. CODA Spinal Concepts, Inc. | MQP |
| May 5, 2004 | K040536 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Apr 16, 2004 | K040482 | EBI ESL SPINE SPACER SYSTEM Ebi, L.P. | MQP |
| Apr 8, 2004 | K040168 | MODIFICATION TO GEO STRUCTURE Interpore Cross Intl. | MQP |
| Mar 31, 2004 | K033702 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM Blackstone Medical, Inc. | MQP |
| Mar 23, 2004 | K040284 | SUSTAIN RADIOLUCENT SPACER Globus Medical, Inc. | MQP |
| Mar 23, 2004 | K033109 | ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS Scient'X | MQP |
| Mar 19, 2004 | K040422 | MODIFICATION TO VERTE-STACK Medtronic Sofamor Danek | MQP |
| Feb 20, 2004 | K032064 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM Theken Surgical,Llc | MQP |
| Feb 18, 2004 | K040167 | VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Feb 18, 2004 | K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS Spinal Concepts, Inc. | MQP |
| Feb 12, 2004 | K032371 | TITANIUM MESH SYSTEM Encore Medical L.P. | MQP |
| Jan 8, 2004 | K033837 | STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM Howmedica Osteonics Corp. | MQP |
| Dec 8, 2003 | K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT Orthovita, Inc. | MQP |
| Nov 13, 2003 | K032476 | NUVASIVE MESH Nuvasive, Inc. | MQP |
| Oct 31, 2003 | K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT Implex Corp. | MQP |
| Oct 9, 2003 | K032700 | BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS Blackstone Medical, Inc. | MQP |
| Aug 7, 2003 | K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM Spinal Concepts, Inc. | MQP |
| Jul 30, 2003 | K031780 | VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Jul 30, 2003 | K031757 | PEEK TETRIS SPINAL IMPLANT Signus Medical, LLC | MQP |
| Jul 12, 2003 | K031914 | SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE Spinal Concepts, Inc. | MQP |
| Jul 11, 2003 | K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. | MQP |
| Jun 27, 2003 | K031302 | SUSTAIN SPACER Globus Medical, Inc. | MQP |
| Jun 27, 2003 | K030744 | BLACKSTONE SURGICAL TITANIUM MESH Blackstone Medical, Inc. | MQP |
| Jun 23, 2003 | K031635 | DEPUY ACROMED VBR SYSTEM Depuyacromed | MQP |
| Apr 18, 2003 | K030735 | MODIFIED VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Apr 10, 2003 | K030833 | DEPUY ACROMED VBR SYSTEM Depuyacromed | MQP |
| Apr 8, 2003 | K022793 | TETRIS SPINAL IMPLANT Signus Medical, LLC | MQP |
| Apr 2, 2003 | K030736 | VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES Medtronic Sofamor Danek | MQP |
| Mar 25, 2003 | K030601 | VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Mar 17, 2003 | K024364 | SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) Synthes (Usa) | MQP |
| Mar 4, 2003 | K023319 | NUVASIVE MASH Nuvasive, Inc. | MQP |
| Feb 26, 2003 | K024049 | VERTE-SPAN SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MQP |
| Feb 14, 2003 | K030249 | SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
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