NextAR TKA Platform

Orthopaedic Surgical Planning And Instrument Guides

Medacta Inernational SA

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

Pre-market Notification Details

Device IDK193559
510k NumberK193559
Device Name:NextAR TKA Platform
ClassificationOrthopaedic Surgical Planning And Instrument Guides
Applicant Medacta Inernational SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodePBF  
Subsequent Product CodeJWH
Subsequent Product CodeOLO
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-07-10

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