The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Anatomic Peek Cervical Fusion System Cornerstone Psr Cervical Fusion System Peek Prevail Cervical Interbody Device Capst.
| Device ID | K122037 |
| 510k Number | K122037 |
| Device Name: | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Becky Ronner |
| Correspondent | Becky Ronner MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MAX |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2013-03-22 |
| Summary: | summary |