The following data is part of a premarket notification filed by Synthes with the FDA for Synthes (usa) Distal Radius Plate System (drps).
| Device ID | K982732 |
| 510k Number | K982732 |
| Device Name: | SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-05 |
| Decision Date | 1998-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792019780 | K982732 | 000 |
| H6792019760 | K982732 | 000 |
| H6792019740 | K982732 | 000 |
| H6792019720 | K982732 | 000 |
| H6792019700 | K982732 | 000 |
| H6792019680 | K982732 | 000 |
| H6792019660 | K982732 | 000 |
| H6792019640 | K982732 | 000 |
| H6792019620 | K982732 | 000 |