The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cannulated Angle Blade Plate.
Device ID | K954289 |
510k Number | K954289 |
Device Name: | SYNTHES CANNULATED ANGLE BLADE PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Angela J Silvestri |
Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | KTW |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-14 |
Decision Date | 1995-11-24 |