ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM is an FDA 510(k)-cleared medical device (K944092) 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 April 3, 1995. Regulation: 8.