The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Satellite Spinal System.
| Device ID | K051320 |
| 510k Number | K051320 |
| Device Name: | SATELLITE SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| 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 | NVR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-09-09 |
| Summary: | summary |