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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, ankle, semi-constrained, cemented, metal/polymer
510(k) Number K120906
Device Name ZIMMER TRABECULAR METAL TOTAL ANKLE
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original Contact rebecca dill
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/26/2012
Decision Date 08/24/2012
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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