BRYAN SPINAL FIXATER (BSF)

BRYAN SPINAL FIXATER (BSF) is an FDA 510(k)-cleared medical device (K914548) manufactured by Arcan Orthopaedic Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 27, 1994. Regulation: 8.