ORTHOFIX TIBIAL NAILING SYSTEM

ORTHOFIX TIBIAL NAILING SYSTEM is an FDA 510(k)-cleared medical device (K961027) manufactured by Orthofix, Inc.. 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 7, 1996. Regulation: 8.