The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Sovereign Spinal System.
| Device ID | K121982 |
| 510k Number | K121982 |
| Device Name: | SOVEREIGN SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000191818 | K121982 | 000 |