The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Titanium Alloy Volar Distal Radius Plate (ti Alloy Vdrp) System.
Device ID | K963798 |
510k Number | K963798 |
Device Name: | SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Angela Silvestri |
Correspondent | Angela Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 1996-09-23 |
Decision Date | 1996-11-27 |
Summary: | summary |