TITANIUM TUBE TO TUBE CLAMP

Component, Traction, Invasive

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Titanium Tube To Tube Clamp.

Pre-market Notification Details

Device IDK960782
510k NumberK960782
Device Name:TITANIUM TUBE TO TUBE CLAMP
ClassificationComponent, Traction, Invasive
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-26
Decision Date1996-05-08
Summary:summary

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