Arthrex Modular Glenoid System-Titanium Glenosphere

Shoulder Prosthesis, Reverse Configuration

Arthrex Inc.

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

Pre-market Notification Details

Device IDK212415
510k NumberK212415
Device Name:Arthrex Modular Glenoid System-Titanium Glenosphere
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactDavid L. Rogers
CorrespondentDavid L. Rogers
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 Received2021-08-03
Decision Date2021-11-17

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.