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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 K122635
Device Name TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
Applicant
Tornier, Inc.
10801 Nesbitt Ave.
Bloomington,  MN  55437
Applicant Contact LAEL J PICKETT
Correspondent
Tornier, Inc.
10801 Nesbitt Ave.
Bloomington,  MN  55437
Correspondent Contact LAEL J PICKETT
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received08/29/2012
Decision Date 05/13/2013
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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