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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 K142419
Device Name Mini and Micro Fragments Reconstruction System-NEOFIX
Applicant
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
RUA ANGELO DOMINGOS DURIGAN, 607, CASCATINHA
curitiba,  BR 82025-100
Applicant Contact mariana de oliveira quinzani
Correspondent
PAXMED INTERNATIONAL, LLC
12264 EL CAMINO REAL
SUITE 400
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/28/2014
Decision Date 12/16/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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