The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa, Inc. with the FDA for Anatomic Peek Ptc Cervical Fusion System.
| Device ID | K160528 |
| 510k Number | K160528 |
| Device Name: | ANATOMIC PEEK PTC Cervical Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANEK, USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK, USA, INC. 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 | 2016-02-25 |
| Decision Date | 2016-03-28 |
| Summary: | summary |