Dark Star Deformity Pedicle Screw System

Dark Star Deformity Pedicle Screw System is an FDA 510(k)-cleared medical device (K223096) manufactured by Republic Spine, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2023. Regulation: 8.