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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 K200895
Device Name Univers Revers Modular Glenoid System, Half Augment Baseplate
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Applicant Contact Ivette Galmez
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Correspondent Contact Ivette Galmez
Regulation Number888.3660
Classification Product Code
PHX  
Date Received04/03/2020
Decision Date 08/13/2020
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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