The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Titanium Tube To Tube Clamp.
Device ID | K960782 |
510k Number | K960782 |
Device Name: | TITANIUM TUBE TO TUBE CLAMP |
Classification | Component, Traction, Invasive |
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 | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-26 |
Decision Date | 1996-05-08 |
Summary: | summary |