ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM

ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM is an FDA 510(k)-cleared medical device (K912420) manufactured by Scientific Research. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 1991. Regulation: 8.