The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Basis Spinal System.
| Device ID | K050484 |
| 510k Number | K050484 |
| Device Name: | BASIS SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharme |
| Correspondent | Richard Treharme MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-05-04 |
| Summary: | summary |