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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
Predetermined Change
Control Plan Authorized		 No
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