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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K110773
Device Name TORNIER INSITE FT SUTURE ANCHOR
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 Number888.3040
Classification Product Code
MBI  
Date Received03/21/2011
Decision Date 06/02/2011
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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