The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Peek Prevail Cervical Interbody Device.
| Device ID | K073285 |
| 510k Number | K073285 |
| Device Name: | PEEK PREVAIL CERVICAL INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Michael Scott |
| Correspondent | Michael Scott MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-23 |
| Decision Date | 2008-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994503435 | K073285 | 000 |
| 00613994502094 | K073285 | 000 |
| 00613994502100 | K073285 | 000 |
| 00613994502117 | K073285 | 000 |
| 00613994502124 | K073285 | 000 |
| 00613994503398 | K073285 | 000 |
| 00613994503404 | K073285 | 000 |
| 00613994503411 | K073285 | 000 |
| 00613994503428 | K073285 | 000 |
| 00613994502087 | K073285 | 000 |