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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 K051623
Device Name ANATOMICAL SHOULDER KEELED GLENOID
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact BRANDON HIPSHER
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact BRANDON HIPSHER
Regulation Number888.3660
Classification Product Code
KWS  
Date Received06/20/2005
Decision Date 07/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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