FIREFLY® Pedicle Screw Navigation Guide

FIREFLY® Pedicle Screw Navigation Guide is an FDA 510(k)-cleared medical device (K253472) manufactured by Mighty Oak Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2026. Regulation: 8.