The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Laurain Dewald Anterior Fixation System.
| Device ID | K023797 |
| 510k Number | K023797 |
| Device Name: | LAURAIN DEWALD ANTERIOR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK 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 | 2002-11-14 |
| Decision Date | 2002-12-13 |
| Summary: | summary |