The Octane Straight Intervertebral Fusion Device, Ti Coated

The Octane Straight Intervertebral Fusion Device, Ti Coated is an FDA 510(k)-cleared medical device (K150152) manufactured by Exactech, 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 May 10, 2015. Regulation: 8.