Navigated LLIF Impactable Tracker

Navigated LLIF Impactable Tracker is an FDA 510(k)-cleared medical device (K261060) manufactured by Tyber Medical, LLC. 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 28, 2026. Regulation: 8.