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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K960278
Device Name COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact LYNETTE WHITAKER
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact LYNETTE WHITAKER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/19/1996
Decision Date 07/25/1996
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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