QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is an FDA 510(k)-cleared medical device (K161591) manufactured by Globus Medical, 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 September 20, 2016. Regulation: 8.