The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Vertex Rcconstruction System.
| Device ID | K121191 |
| 510k Number | K121191 |
| Device Name: | VERTEX RCCONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Claire Evans |
| Correspondent | Claire Evans MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-19 |
| Decision Date | 2012-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994531803 | K121191 | 000 |
| 00613994531797 | K121191 | 000 |
| 00613994531780 | K121191 | 000 |
| 00613994531773 | K121191 | 000 |
| 00613994531766 | K121191 | 000 |
| 00613994531759 | K121191 | 000 |