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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
Device Name X-FIX DYNAMIC EXTERNAL DISTRACTOR
Applicant
Arex USA, LLC
1709 Hill St.
Edgewater,  FL  32132
Applicant Contact CHARLES HOKANSON
Correspondent
Arex USA, LLC
1709 Hill St.
Edgewater,  FL  32132
Correspondent Contact CHARLES HOKANSON
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/08/2012
Decision Date 03/15/2013
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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