The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Rapid Resorbable Fixation System.
| Device ID | K062789 |
| 510k Number | K062789 |
| Device Name: | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey Dow |
| Correspondent | Jeffrey Dow SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2007-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98085163501S0 | K062789 | 000 |