Solanas® Posterior OCT Fixation System

Solanas® Posterior OCT Fixation System is an FDA 510(k)-cleared medical device (K191185) manufactured by Alphatec Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2019. Regulation: 8.