SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K950099) manufactured by Buckman 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 January 15, 1997. Regulation: 8.