The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix System.
| Device ID | K011969 |
| 510k Number | K011969 |
| Device Name: | SYNTHES CERVIFIX SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-25 |
| Decision Date | 2001-07-19 |
| Summary: | summary |