Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is an FDA 510(k)-cleared medical device (K160775) manufactured by Choicespine, LP. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2016. Regulation: 8.