The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Perimeter C (titanium) Spinal System.
| Device ID | K153438 |
| 510k Number | K153438 |
| Device Name: | PERIMETER C (Titanium) Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Michael Scott |
| Correspondent | Ankit K Shah MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169584389 | K153438 | 000 |
| 00643169584242 | K153438 | 000 |
| 00643169584259 | K153438 | 000 |
| 00643169584266 | K153438 | 000 |
| 00643169584273 | K153438 | 000 |
| 00643169584280 | K153438 | 000 |
| 00643169584297 | K153438 | 000 |
| 00643169584303 | K153438 | 000 |
| 00643169584310 | K153438 | 000 |
| 00643169584327 | K153438 | 000 |
| 00643169584334 | K153438 | 000 |
| 00643169584341 | K153438 | 000 |
| 00643169584358 | K153438 | 000 |
| 00643169584365 | K153438 | 000 |
| 00643169584372 | K153438 | 000 |
| 00643169584235 | K153438 | 000 |