Shoulder System - TiNbN Coating

Shoulder Prosthesis, Reverse Configuration

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Shoulder System - Tinbn Coating.

Pre-market Notification Details

Device IDK203755
510k NumberK203755
Device Name:Shoulder System - TiNbN Coating
ClassificationShoulder Prosthesis, Reverse Configuration
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 CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeMBF
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-03-02

NIH GUDID Devices

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