QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is an FDA 510(k)-cleared medical device (K231850) 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 March 13, 2024. Regulation: 8.