The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Perimeter C Spinal System.
| Device ID | K132584 |
| 510k Number | K132584 |
| Device Name: | PERIMETER C 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 | Michael Scott 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 | 2013-08-16 |
| Decision Date | 2013-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169200746 | K132584 | 000 |
| 00643169200609 | K132584 | 000 |
| 00643169200616 | K132584 | 000 |
| 00643169200623 | K132584 | 000 |
| 00643169200630 | K132584 | 000 |
| 00643169200647 | K132584 | 000 |
| 00643169200654 | K132584 | 000 |
| 00643169200661 | K132584 | 000 |
| 00643169200678 | K132584 | 000 |
| 00643169200685 | K132584 | 000 |
| 00643169200692 | K132584 | 000 |
| 00643169200708 | K132584 | 000 |
| 00643169200715 | K132584 | 000 |
| 00643169200722 | K132584 | 000 |
| 00643169200739 | K132584 | 000 |
| 00643169200593 | K132584 | 000 |