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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K113733
Device Name SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
Original Applicant
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 el camino real
suite 200
san diego,  CA  92130
Original Contact kevin a thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/19/2011
Decision Date 03/23/2012
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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