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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 avenue
bloomington,  MN  55437
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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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