NextGen Pedicle Screw System

NextGen Pedicle Screw System is an FDA 510(k)-cleared medical device (K221776) manufactured by Corelink, 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 August 8, 2022. Regulation: 8.