Haymaker® Screw System

Haymaker® Screw System is an FDA 510(k)-cleared medical device (K222799) manufactured by Orthocircle Spine D.B.A. OC Medical Devices. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2023. Regulation: 8.