The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Sustain Space Maintenance System.
| Device ID | K100779 |
| 510k Number | K100779 |
| Device Name: | SUSTAIN SPACE MAINTENANCE SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Michelle Obenauer |
| Correspondent | Michelle Obenauer MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994802538 | K100779 | 000 |
| 20613994792383 | K100779 | 000 |
| 20613994792376 | K100779 | 000 |
| 20613994792369 | K100779 | 000 |
| 20613994792352 | K100779 | 000 |
| 20613994792345 | K100779 | 000 |
| 20613994792338 | K100779 | 000 |
| 20613994792321 | K100779 | 000 |
| 20613994792314 | K100779 | 000 |