The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Resorbable Fixation System.
| Device ID | K021928 |
| 510k Number | K021928 |
| Device Name: | SYNTHES (USA) RESORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2002-09-06 |
| Summary: | summary |