Gibralt® Spine System and Gibralt® Occipital Spine System

Gibralt® Spine System and Gibralt® Occipital Spine System is an FDA 510(k)-cleared medical device (K160697) manufactured by Exactech, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2016. Regulation: 8.