SYNERGY SPINAL SYSTEM (6.35 POLARIS)

SYNERGY SPINAL SYSTEM (6.35 POLARIS) is an FDA 510(k)-cleared medical device (K081952) manufactured by Biomet 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 October 6, 2008. Regulation: 8.