VERTEFIX PEDICLE SCREW SPINAL SYSTEM

VERTEFIX PEDICLE SCREW SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K063453) manufactured by Elite Surgical Supplies (Pty), Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2007. Regulation: 8.