ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING

ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING is an FDA 510(k)-cleared medical device (K974186) 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 March 17, 1998. Regulation: 8.