Calvary Spine Pedicle Screw System

Calvary Spine Pedicle Screw System is an FDA 510(k)-cleared medical device (K201568) manufactured by Calvary 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 November 11, 2020. Regulation: 8.