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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, non-constrained, metal/polymer cemented
510(k) Number K041549
Device Name ZIMMER TRABECULAR METAL HUMERAL STEM
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact DALENE BINKLEY
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact DALENE BINKLEY
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received06/09/2004
Decision Date 09/01/2004
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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