The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes Cervifix System.
Device ID | K030377 |
510k Number | K030377 |
Device Name: | MODIFICATION TO SYNTHES CERVIFIX SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Vikki M Hoffman |
Correspondent | Vikki M Hoffman SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-05 |
Decision Date | 2003-03-06 |
Summary: | summary |