GEO Bone Screw System

GEO Bone Screw System is an FDA 510(k)-cleared medical device (K161904) manufactured by Gramercy Extremity Orthopeidics, 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 January 17, 2017. Regulation: 8.