The following data is part of a premarket notification filed by Sofamor Co. with the FDA for Sofamor, Laurain Dewald Anterior Fixation.
| Device ID | K940744 |
| 510k Number | K940744 |
| Device Name: | SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SOFAMOR CO. 158, RUE DE L'EGLISE - B.P.4 62180 RANG DU FLIERS France, FR |
| Contact | Brian Gooden |
| Correspondent | Brian Gooden SOFAMOR CO. 158, RUE DE L'EGLISE - B.P.4 62180 RANG DU FLIERS France, FR |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-17 |
| Decision Date | 1996-01-30 |