
Neoortho Produtos Ortopedicos S/A
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SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX is an FDA 510(k)-cleared medical device (K113733) manufactured by Neoortho Produtos Ortopedicos S/A. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2012. Regulation: 8.