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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 K112675
Device Name ARROW-LOK DIGITAL SYSTEM
Applicant
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
328 poplar view lane east
suite 2
collierville,  TN  38017
Contact thomas j twardzik
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/14/2011
Decision Date 12/12/2011
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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