The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Peek Prevail Cervical Interbody Device.
| Device ID | K094042 |
| 510k Number | K094042 |
| Device Name: | PEEK PREVAIL CERVICAL INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Justine Viera |
| Correspondent | Justine Viera MEDTRONIC SOFAMOR DANEK 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 | 2009-12-30 |
| Decision Date | 2010-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994646019 | K094042 | 000 |
| 00613994351128 | K094042 | 000 |
| 00613994309495 | K094042 | 000 |
| 00613994309488 | K094042 | 000 |
| 00721902862366 | K094042 | 000 |
| 00721902862311 | K094042 | 000 |
| 00721902862267 | K094042 | 000 |
| 00721902862229 | K094042 | 000 |
| 00721902862175 | K094042 | 000 |
| 00721902862168 | K094042 | 000 |
| 00721902862151 | K094042 | 000 |
| 00721902862144 | K094042 | 000 |
| 00613994392756 | K094042 | 000 |
| 00613994451231 | K094042 | 000 |
| 00613994646002 | K094042 | 000 |
| 00613994645999 | K094042 | 000 |
| 00613994645982 | K094042 | 000 |
| 00613994645975 | K094042 | 000 |
| 00613994645777 | K094042 | 000 |
| 00613994645760 | K094042 | 000 |
| 00613994645753 | K094042 | 000 |
| 00613994645746 | K094042 | 000 |
| 00613994645739 | K094042 | 000 |
| 00613994504470 | K094042 | 000 |
| 00613994503442 | K094042 | 000 |
| 00721902634376 | K094042 | 000 |