The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To: Satellite Spinal System.
| Device ID | K060415 |
| 510k Number | K060415 |
| Device Name: | MODIFICATION TO: 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 Treharne |
| Correspondent | Richard 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 | 2006-02-17 |
| Decision Date | 2007-01-05 |
| Summary: | summary |