UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K943725) manufactured by Synthes Spine. 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 24, 1995. Regulation: 8.