The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix System.
Device ID | K994187 |
510k Number | K994187 |
Device Name: | SYNTHES CERVIFIX SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Contact | Jonathan Gilbert |
Correspondent | Jonathan 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-13 |
Decision Date | 1999-12-21 |
Summary: | summary |