MODIFICATION TO SYNTHES (USA) POLYPIN

Pin, Fixation, Smooth

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK003527
510k NumberK003527
Device Name:MODIFICATION TO SYNTHES (USA) POLYPIN
ClassificationPin, Fixation, Smooth
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactThomas M Maguire
CorrespondentThomas M Maguire
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 Received2000-11-16
Decision Date2001-04-09

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