The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System, Extra Small Sizes.
| Device ID | K030736 |
| 510k Number | K030736 |
| Device Name: | VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902913204 | K030736 | 000 |
| 00721902807459 | K030736 | 000 |
| 00721902807435 | K030736 | 000 |
| 00721902807428 | K030736 | 000 |
| 00721902807411 | K030736 | 000 |
| 00721902807398 | K030736 | 000 |
| 00721902807367 | K030736 | 000 |
| 00721902807350 | K030736 | 000 |
| 00721902807336 | K030736 | 000 |
| 00721902807329 | K030736 | 000 |
| 00721902807305 | K030736 | 000 |
| 00721902807299 | K030736 | 000 |
| 00721902807282 | K030736 | 000 |
| 00721902807275 | K030736 | 000 |
| 00721902807268 | K030736 | 000 |
| 00721902807251 | K030736 | 000 |
| 00721902807473 | K030736 | 000 |
| 00721902807480 | K030736 | 000 |
| 00721902807497 | K030736 | 000 |
| 00721902913198 | K030736 | 000 |
| 00721902913181 | K030736 | 000 |
| 00721902913174 | K030736 | 000 |
| 00721902913167 | K030736 | 000 |
| 00721902913150 | K030736 | 000 |
| 00721902807596 | K030736 | 000 |
| 00721902807589 | K030736 | 000 |
| 00721902807572 | K030736 | 000 |
| 00721902807565 | K030736 | 000 |
| 00721902807558 | K030736 | 000 |
| 00721902807541 | K030736 | 000 |
| 00721902807534 | K030736 | 000 |
| 00721902807527 | K030736 | 000 |
| 00721902807510 | K030736 | 000 |
| 00721902807503 | K030736 | 000 |
| 00763000857387 | K030736 | 000 |