The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Vertex Reconstruction System And Vertex Select Reconstruction System.
| Device ID | K093434 |
| 510k Number | K093434 |
| Device Name: | VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Melisa L Weisman |
| Correspondent | Melisa L Weisman MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-04 |
| Decision Date | 2009-12-02 |
| Summary: | summary |