The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System.
| Device ID | K030601 |
| 510k Number | K030601 |
| Device Name: | VERTE-STACK SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W 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 | 2003-02-25 |
| Decision Date | 2003-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994324092 | K030601 | 000 |
| 00613994324085 | K030601 | 000 |
| 00613994324078 | K030601 | 000 |
| 00613994324054 | K030601 | 000 |
| 00613994324047 | K030601 | 000 |
| 00613994324030 | K030601 | 000 |
| 00613994324023 | K030601 | 000 |
| 00613994239556 | K030601 | 000 |