The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Resorbable Fixation System.
| Device ID | K974554 |
| 510k Number | K974554 |
| Device Name: | SYNTHES RESORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-04 |
| Decision Date | 1998-02-24 |
| Summary: | summary |