The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Volar Distal Radius Plate.
| Device ID | K953644 |
| 510k Number | K953644 |
| Device Name: | VOLAR DISTAL RADIUS PLATE |
| Classification | Plate, Fixation, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794019700 | K953644 | 000 |
| H6794019640 | K953644 | 000 |
| H6794019660 | K953644 | 000 |
| H6794019680 | K953644 | 000 |
| H6794019720 | K953644 | 000 |
| H6794019740 | K953644 | 000 |
| H6794019760 | K953644 | 000 |
| H6794019780 | K953644 | 000 |
| H6794019800 | K953644 | 000 |
| H6794019620 | K953644 | 000 |