NextAR RSA Platform

Orthopedic Stereotaxic Instrument

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Nextar Rsa Platform.

Pre-market Notification Details

Device IDK210153
510k NumberK210153
Device Name:NextAR RSA Platform
ClassificationOrthopedic Stereotaxic Instrument
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 CodeOLO  
Subsequent Product CodeJWH
Subsequent Product CodeLLZ
Subsequent Product CodePBF
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-05-12

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