Solanas® Posterior Stabilization System

Solanas® Posterior Stabilization System is an FDA 510(k)-cleared medical device (K173522) manufactured by Alphatec 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 29, 2017. Regulation: 8.