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 | K100967 |
| 510k Number | K100967 |
| 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 | Brad Sheals |
| Correspondent | Brad Sheals 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 | 2010-04-08 |
| Decision Date | 2011-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994351289 | K100967 | 000 |
| 00613994351142 | K100967 | 000 |
| 00613994351159 | K100967 | 000 |
| 00613994351166 | K100967 | 000 |
| 00613994351173 | K100967 | 000 |
| 00613994351180 | K100967 | 000 |
| 00613994351197 | K100967 | 000 |
| 00613994351203 | K100967 | 000 |
| 00613994351210 | K100967 | 000 |
| 00613994351227 | K100967 | 000 |
| 00613994351234 | K100967 | 000 |
| 00613994351241 | K100967 | 000 |
| 00613994351258 | K100967 | 000 |
| 00613994351265 | K100967 | 000 |
| 00613994351272 | K100967 | 000 |
| 00613994351135 | K100967 | 000 |