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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K090139
Device Name ANKLE ARTHRODESIS PLATE SYSTEM
Applicant
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact BRAHIM HADRI
Correspondent
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact BRAHIM HADRI
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/21/2009
Decision Date 10/27/2009
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
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