GMA 2.0 Pedicle Screw System

GMA 2.0 Pedicle Screw System is an FDA 510(k)-cleared medical device (K192915) manufactured by Grafton Medical Alliance. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2019. Regulation: 8.