SYNTHES (U.S.A.) POLYPIN

Pin, Fixation, Smooth

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Polypin.

Pre-market Notification Details

Device IDK961608
510k NumberK961608
Device Name:SYNTHES (U.S.A.) POLYPIN
ClassificationPin, Fixation, Smooth
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 CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-25
Decision Date1997-05-09
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.