SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE is an FDA 510(k)-cleared medical device (K952298) manufactured by J.B.S., S.A.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1995. Regulation: 8.