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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 K193372
Device Name Univers Revers Modular Glenoid System (Augemented baseplates)
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Ivette Galmez
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Ivette Galmez
Regulation Number888.3660
Classification Product Code
PHX  
Date Received12/05/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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