IBIS PEDICLE SCREW SYSTEM

IBIS PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K142146) manufactured by Ortho Development 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 10, 2014. Regulation: 8.