Medacta Shoulder System

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 Medacta Shoulder System.

Pre-market Notification Details

Device IDK192967
510k NumberK192967
Device Name:Medacta Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Medacta International, SA Strada Regina Castel San Pietro,  CH 6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2020-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07630040734097 K192967 000
07630040733977 K192967 000

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