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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 K050761
Device Name ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
Applicant
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Applicant Contact DARLENE BINKLEY
Correspondent
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Correspondent Contact DARLENE BINKLEY
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received03/24/2005
Decision Date 04/11/2005
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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