Ibis® Pedicle Screw System

Ibis® Pedicle Screw System is an FDA 510(k)-cleared medical device (K162995) manufactured by Ortho Development Corporation. 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 29, 2017. Regulation: 8.