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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 K172502
Device Name Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Patricia Sandborn Beres
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Patricia Sandborn Beres
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT   MBF   PAO  
Date Received08/18/2017
Decision Date 01/03/2018
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
Recalls CDRH Recalls
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