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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 K170414
Device Name Arthrex Univers Revers Apex Humeral Stems
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact David L. Rogers
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact David L. Rogers
Regulation Number888.3660
Classification Product Code
PHX  
Date Received02/10/2017
Decision Date 12/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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