CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments is an FDA 510(k)-cleared medical device (K191835) 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 August 5, 2019. Regulation: 8.