SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM

SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K141397) manufactured by Precision Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2014. Regulation: 8.