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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K112990
Device Name ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
Original Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact christina flores
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
GAT  
Date Received10/06/2011
Decision Date 12/19/2011
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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