The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modified Verte-stack Spinal System.
| Device ID | K030735 |
| 510k Number | K030735 |
| Device Name: | MODIFIED VERTE-STACK SPINAL SYSTEM |
| 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 | 2003-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902984532 | K030735 | 000 |
| 00721902984471 | K030735 | 000 |
| 00721902984464 | K030735 | 000 |
| 00721902984457 | K030735 | 000 |
| 00721902984440 | K030735 | 000 |
| 00721902984341 | K030735 | 000 |
| 00721902984334 | K030735 | 000 |
| 00721902984198 | K030735 | 000 |