The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Xantus Anterior Lateral Supplemental Fixation System.
| Device ID | K022070 |
| 510k Number | K022070 |
| Device Name: | XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 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 | 2002-06-26 |
| Decision Date | 2002-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902227394 | K022070 | 000 |
| 00721902226786 | K022070 | 000 |
| 00721902225796 | K022070 | 000 |
| 00721902225345 | K022070 | 000 |
| 00721902225000 | K022070 | 000 |