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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 K113828
Model 1200-01, 1200-02-50XX, 1200-03-5XXX, 2200-01-0000
Device Name DYNANAIL ANKLE ARTHRODESIS NAIL
Original Applicant
MEDSHAPE, INC
1575 northside drive,
suite 440
atlanta,  GA  30318
Original Contact jeremy blair
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/28/2011
Decision Date 02/29/2012
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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