Navigated INFINITY Instruments

Navigated INFINITY Instruments is an FDA 510(k)-cleared medical device (K181111) manufactured by Medtronic Sofamor Danek USA, 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 May 16, 2018. Regulation: 8.