The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Axis Fixation System.
| Device ID | K062254 |
| 510k Number | K062254 |
| Device Name: | AXIS FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Edward Chin |
| Correspondent | Edward Chin MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | HRS |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKG |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2008-06-16 |
| Summary: | summary |