The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.7 Mm Lc-dcp, 3.5 Mm Profile.
Device ID | K011170 |
510k Number | K011170 |
Device Name: | SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Thomas M Maguire |
Correspondent | Thomas M Maguire SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-17 |
Decision Date | 2001-07-05 |