BRYAN POSTERIOR SPINAL FIXATOR (BPSF)

BRYAN POSTERIOR SPINAL FIXATOR (BPSF) is an FDA 510(k)-cleared medical device (K953416) 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 October 2, 1995. Regulation: 8.