The following data is part of a premarket notification filed by Sofamor Co. with the FDA for Apofix Cervical Spine Fixation.
| Device ID | K945022 |
| 510k Number | K945022 |
| Device Name: | APOFIX CERVICAL SPINE FIXATION |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR CO. 60, 62 RUE ROTHSCHILD Berck/mer, FR 62600 |
| Contact | Brian Gooden |
| Correspondent | Brian Gooden SOFAMOR CO. 60, 62 RUE ROTHSCHILD Berck/mer, FR 62600 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1995-05-15 |