Headless Compression Screw System

Headless Compression Screw System is an FDA 510(k)-cleared medical device (K200259) manufactured by Osteocentric Extremities, LLC. 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 3, 2020. Regulation: 8.