The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is an FDA 510(k)-cleared medical device (K170942) 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 April 25, 2017. Regulation: 8.