The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Spine Cervifix System.
| Device ID | K984377 |
| 510k Number | K984377 |
| Device Name: | SYNTHES SPINE CERVIFIX SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Contact | Jonathan M Gilbert |
| Correspondent | Jonathan M Gilbert SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-03 |
| Decision Date | 1999-01-21 |
| Summary: | summary |