The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Vertex Reconstruction System.
| Device ID | K081297 |
| 510k Number | K081297 |
| Device Name: | VERTEX RECONSTRUCTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert MEDTRONIC SOFAMOR DANEK 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 | 2008-05-07 |
| Decision Date | 2008-06-11 |
| Summary: | summary |