STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW is an FDA 510(k)-cleared medical device (K130731) manufactured by Stabiliz Orthopaedics, 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 July 18, 2013. Regulation: 8.