Univers Revers Modular Glenoid System, Standard Augment Baseplates

Shoulder Prosthesis, Reverse Configuration

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Univers Revers Modular Glenoid System, Standard Augment Baseplates.

Pre-market Notification Details

Device IDK211074
510k NumberK211074
Device Name:Univers Revers Modular Glenoid System, Standard Augment Baseplates
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactIvette Galmez
CorrespondentIvette Galmez
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-09-02

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