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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
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact REBECCA DILL
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent 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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