Cortera Spinal Fixation System

Cortera Spinal Fixation System is an FDA 510(k)-cleared medical device (K221403) manufactured by Surgalign Spine Technologies. 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 18, 2022. Regulation: 8.