SPIRA® Anterior Lumbar Spacers

SPIRA® Anterior Lumbar Spacers is an FDA 510(k)-cleared medical device (K234077) manufactured by Camber 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 July 11, 2024. Regulation: 8.