Xultan 5.5 Pedicle Screw System

Xultan 5.5 Pedicle Screw System is an FDA 510(k)-cleared medical device (K170108) manufactured by Met One Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2017. Regulation: 8.