Golden Isles Pedicle Screw System

Golden Isles Pedicle Screw System is an FDA 510(k)-cleared medical device (K212185) manufactured by Intelivation, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 2021. Regulation: 8.