Humeral Eccentric Reverse Metaphysis

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 Humeral Eccentric Reverse Metaphysis.

Pre-market Notification Details

Device IDK210207
510k NumberK210207
Device Name:Humeral Eccentric Reverse Metaphysis
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  83118
Product CodePHX  
Subsequent Product CodeKWS
Subsequent Product CodeMBF
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-26
Decision Date2021-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345716781 K210207 000

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