Inertia Pedicle Screw and Deformity Correxxion System

Inertia Pedicle Screw and Deformity Correxxion System is an FDA 510(k)-cleared medical device (K153453) manufactured by Nexxt 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 April 25, 2016. Regulation: 8.