FLOSPINE PEDICLE SCREW SYSTEM

FLOSPINE PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K141850) manufactured by Flospine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2014. Regulation: 8.