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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 K062029
Device Name ANATOMICAL SHOULDER FRACTURE SYSTEM
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact MASON W ROBBINS
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact MASON W ROBBINS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received07/18/2006
Decision Date 10/31/2006
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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