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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, Biodegradable, Soft Tissue
510(k) Number K083268
Device Name TORNIER, INC., INSITE SUTURE ANCHORS
Applicant
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact HOWARD L SCHRAYER
Correspondent
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact HOWARD L SCHRAYER
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received11/05/2008
Decision Date 02/12/2009
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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