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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K212415
Device Name Arthrex Modular Glenoid System-Titanium Glenosphere
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact David L. Rogers
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact David L. Rogers
Regulation Number888.3660
Classification Product Code
PHX  
Date Received08/03/2021
Decision Date 11/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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