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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 K060704
Device Name ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact DALENE T BINKLEY
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   KWT  
Date Received03/16/2006
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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