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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K133834
Device Name DEPUY GLOBAL UNITE SHOULDER SYSTEM
Applicant
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
CO. CORK,  IE IRELAND
Applicant Contact KELLIE MYERS
Correspondent
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
CO. CORK,  IE IRELAND
Correspondent Contact KELLIE MYERS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received12/17/2013
Decision Date 04/03/2014
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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