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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K121575
Device Name OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Original Applicant
ORTHO SOLUTIONS LIMITED
3150 east 200th street
prior lake,  MN  55372
Original Contact al lippincott
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/30/2012
Decision Date 09/14/2012
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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