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 | K113252 |
| 510k Number | K113252 |
| 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 | Kristi Frisch |
| Correspondent | Kristi Frisch 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 | 2011-11-03 |
| Decision Date | 2012-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994853264 | K113252 | 000 |
| 00613994753922 | K113252 | 000 |