The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Articulating Distal Radius (adrf) System.
| Device ID | K984498 |
| 510k Number | K984498 |
| Device Name: | SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-17 |
| Decision Date | 1999-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793940500 | K984498 | 000 |