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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 K122415
Model X-FIX
Device Name X-FIX DYNAMIC EXTERNAL DISTRACTOR
Applicant
AREX USA LLC
1709 hill st.
edgewater,  FL  32132
Contact charles hokanson
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/08/2012
Decision Date 03/15/2013
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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