Navigated INFINITY™ Instruments

Navigated INFINITY™ Instruments is an FDA 510(k)-cleared medical device (K173338) 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 January 17, 2018. Regulation: 8.