Arthrex Univers Revers Modular Glenoid System

Shoulder Prosthesis, Reverse Configuration

Arthrex Inc.

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

Pre-market Notification Details

Device IDK191960
510k NumberK191960
Device Name:Arthrex Univers Revers Modular Glenoid System
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-23
Decision Date2019-12-23
Summary:summary

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