The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Vertex Reconstruction System.
| Device ID | K071942 |
| 510k Number | K071942 |
| Device Name: | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Michelle Willis |
| Correspondent | Michelle Willis MEDTRONIC SOFAMOR DANEK 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 | 2007-07-13 |
| Decision Date | 2007-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994514493 | K071942 | 000 |
| 00613994237637 | K071942 | 000 |
| 00613994237675 | K071942 | 000 |
| 00613994237682 | K071942 | 000 |
| 00613994237699 | K071942 | 000 |
| 00613994237705 | K071942 | 000 |
| 00613994237712 | K071942 | 000 |
| 00613994237729 | K071942 | 000 |
| 00613994237736 | K071942 | 000 |
| 00613994237873 | K071942 | 000 |
| 00613994237880 | K071942 | 000 |
| 00613994237897 | K071942 | 000 |
| 00613994237903 | K071942 | 000 |
| 00613994237910 | K071942 | 000 |
| 00613994244451 | K071942 | 000 |
| 00613994244468 | K071942 | 000 |
| 00613994302823 | K071942 | 000 |
| 00613994237620 | K071942 | 000 |