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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K112885
Device Name ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original Contact stephen h mckelvey
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received09/30/2011
Decision Date 12/19/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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