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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
FOIA Releasable 510(k) 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 (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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