NEOPLATE SPINE ANTERIOR FIXATION SYSTEM

NEOPLATE SPINE ANTERIOR FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K132653) manufactured by Neoortho Productos Orthopedicos 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 May 13, 2014. Regulation: 8.