Mectaplug PE II

Prosthesis, Hip, Cement Restrictor

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectaplug Pe Ii.

Pre-market Notification Details

Device IDK210062
510k NumberK210062
Device Name:Mectaplug PE II
ClassificationProsthesis, Hip, Cement Restrictor
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  83118
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2021-04-08

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