The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile Pinless External Fixator.
Device ID | K925460 |
510k Number | K925460 |
Device Name: | SYNTHES STERILE PINLESS EXTERNAL FIXATOR |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Alan I Becker |
Correspondent | Alan I Becker SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-29 |
Decision Date | 1994-03-10 |