CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® is an FDA 510(k)-cleared medical device (K182375) 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 April 7, 2019. Regulation: 8.