VITALLIUM HEX-DRIVE BONE SCREW SYSTEM

VITALLIUM HEX-DRIVE BONE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K864633) manufactured by Howmedica 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 December 17, 1986. Regulation: 8.