510(k) K113733

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX by Neoortho Produtos Ortopedicos S/A — Product Code HRS

K113733 is an FDA 510(k) premarket notification submitted by Neoortho Produtos Ortopedicos S/A for the device "SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX". The FDA issued a decision of Substantially Equivalent on Mar 23, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Neoortho Produtos Ortopedicos S/A has 4 other 510(k) clearances on record.