The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Titanium Locked Spiked Washer.
Device ID | K924455 |
510k Number | K924455 |
Device Name: | SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER |
Classification | Washer, Bolt Nut |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Diane Cochet-wynant |
Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-02 |
Decision Date | 1993-05-12 |