CORTICAL BONE SCREW (EUROPEAN STYLE)

CORTICAL BONE SCREW (EUROPEAN STYLE) is an FDA 510(k)-cleared medical device (K905357) manufactured by O'Tec Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 1991. Regulation: 8.