The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Capstone Spinal System.
| Device ID | K082342 |
| 510k Number | K082342 |
| Device Name: | MODIFICATION TO CAPSTONE SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Contact | Chris Mckee |
| Correspondent | Chris Mckee MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2008-09-12 |
| Summary: | summary |