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 | K053483 |
| 510k Number | K053483 |
| Device Name: | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-01-05 |
| Summary: | summary |