M.U.S.T. Mini Extension

Posterior Cervical Screw System

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Mini Extension.

Pre-market Notification Details

Device IDK182837
510k NumberK182837
Device Name:M.U.S.T. Mini Extension
ClassificationPosterior Cervical Screw System
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-09
Decision Date2019-01-22
Summary:summary

NIH GUDID Devices

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