The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Bioresorbable Suture Anchor.
Device ID | K994161 |
510k Number | K994161 |
Device Name: | SYNTHES BIORESORBABLE SUTURE ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-09 |
Decision Date | 2000-07-28 |
Summary: | summary |