
Apogee Orthosolutions
Free shipping on orders over $99 · 30-day returns
MONSTER SCREW SYSTEM is an FDA 510(k)-cleared medical device (K124027) manufactured by Apogee Orthosolutions. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2013. Regulation: 8.