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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 K101996
Device Name DEPUY GLOBAL UNITE SHOULDER SYSTEM
Applicant
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
CO. CORK,  IE
Applicant Contact RHONDA MYER
Correspondent
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
CO. CORK,  IE
Correspondent Contact RHONDA MYER
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   MBF  
Date Received07/15/2010
Decision Date 12/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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