The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Sovereign Spinal System.
| Device ID | K110063 |
| 510k Number | K110063 |
| Device Name: | SOVEREIGN SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Mike Scott |
| Correspondent | Mike Scott MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994736611 | K110063 | 000 |
| 00613994736598 | K110063 | 000 |
| 00613994736574 | K110063 | 000 |
| 00613994736550 | K110063 | 000 |
| 00613994736536 | K110063 | 000 |
| 00613994736512 | K110063 | 000 |
| 00613994736499 | K110063 | 000 |
| 00613994736475 | K110063 | 000 |