OsteoBullet Compression Screw

OsteoBullet Compression Screw is an FDA 510(k)-cleared medical device (K160304) manufactured by Phalanx Innovations. 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 28, 2016. Regulation: 8.