Atlas Spine HiRISE™ Expandable Cervical Corpectomy System

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is an FDA 510(k)-cleared medical device (K252560) manufactured by Atlas Spine, Inc.. 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 9, 2025. Regulation: 8.