The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cornerstone Psr Cervical Fusion System, Perimeter C Spinal System, Peek Prevail Cervical Interbody Device.
| Device ID | K153373 |
| 510k Number | K153373 |
| Device Name: | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Sneh Pingle |
| Correspondent | Sneh Pingle Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-01-19 |
| Summary: | summary |