NAVIO™ Surgical System (NAVIO system)

NAVIO™ Surgical System (NAVIO system) is an FDA 510(k)-cleared medical device (K180271) manufactured by Blue Belt Technologies, 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 April 5, 2018. Regulation: 8.