OEC/REZAIAN SPINAL FIXATOR

OEC/REZAIAN SPINAL FIXATOR is an FDA 510(k)-cleared medical device (K841189) manufactured by Orthopedic Equipment Co., 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 May 15, 1984. Regulation: 8.