The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Polypin.
Device ID | K003527 |
510k Number | K003527 |
Device Name: | MODIFICATION TO SYNTHES (USA) POLYPIN |
Classification | Pin, Fixation, Smooth |
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 | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-16 |
Decision Date | 2001-04-09 |