The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Cd Spinal System.
| Device ID | K000476 |
| 510k Number | K000476 |
| Device Name: | MODIFICATION TO CD SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978053158 | K000476 | 000 |
| 00721902575259 | K000476 | 000 |
| 00721902575273 | K000476 | 000 |
| 00721902575280 | K000476 | 000 |
| 00721902575327 | K000476 | 000 |
| 00721902575334 | K000476 | 000 |
| 00721902575341 | K000476 | 000 |
| 00721902575358 | K000476 | 000 |
| 00721902575372 | K000476 | 000 |
| 00721902694653 | K000476 | 000 |
| 00721902694660 | K000476 | 000 |
| 00721902575242 | K000476 | 000 |