ExcelsiusGPS Cranial 1.0 Module

ExcelsiusGPS Cranial 1.0 Module is an FDA 510(k)-cleared medical device (K200047) manufactured by Globus Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2020. Regulation: 8.