The following data is part of a premarket notification filed by Sofamor Co. with the FDA for Sofamor Orfil Spine Fixation System.
| Device ID | K934007 |
| 510k Number | K934007 |
| Device Name: | SOFAMOR ORFIL SPINE FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR CO. 158 RUE DE L'ENGLISE B.P. 4 RANG-DU-FLIERS 62180 France, FR |
| Contact | Brian Gooden |
| Correspondent | Brian Gooden SOFAMOR CO. 158 RUE DE L'ENGLISE B.P. 4 RANG-DU-FLIERS 62180 France, FR |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-18 |
| Decision Date | 1994-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490717254 | K934007 | 000 |
| 20673978017826 | K934007 | 000 |
| 20673978017758 | K934007 | 000 |
| 20613994346227 | K934007 | 000 |