The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Vantage Anterior Fixation System.
| Device ID | K031533 |
| 510k Number | K031533 |
| Device Name: | VANTAGE ANTERIOR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994839305 | K031533 | 000 |
| 00721902842429 | K031533 | 000 |
| 00721902842412 | K031533 | 000 |
| 00721902842405 | K031533 | 000 |
| 00721902842399 | K031533 | 000 |
| 00721902842382 | K031533 | 000 |
| 00721902842375 | K031533 | 000 |
| 00721902842368 | K031533 | 000 |
| 00885074338644 | K031533 | 000 |
| 00885074338637 | K031533 | 000 |
| 00885074338620 | K031533 | 000 |
| 00885074338613 | K031533 | 000 |
| 00885074338606 | K031533 | 000 |
| 00721902842436 | K031533 | 000 |
| 00721902842443 | K031533 | 000 |
| 00721902842450 | K031533 | 000 |
| 00613994839299 | K031533 | 000 |
| 00613994839282 | K031533 | 000 |
| 00613994839275 | K031533 | 000 |
| 00613994839268 | K031533 | 000 |
| 00613994839251 | K031533 | 000 |
| 00613994839244 | K031533 | 000 |
| 00613994839237 | K031533 | 000 |
| 00613994839220 | K031533 | 000 |
| 00613994839213 | K031533 | 000 |
| 00613994839206 | K031533 | 000 |
| 00613994839190 | K031533 | 000 |
| 00613994839183 | K031533 | 000 |
| 00885074338590 | K031533 | 000 |