The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Modified Bioresorbable Suture Anchor System.
| Device ID | K003743 |
| 510k Number | K003743 |
| Device Name: | SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MAI |
| Subsequent Product Code | GAS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-02-09 |