ORTHOFIX FEMORAL NAILING SYTEM

ORTHOFIX FEMORAL NAILING SYTEM is an FDA 510(k)-cleared medical device (K973944) manufactured by Orthofix Srl. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 1997. Regulation: 8.