POLARIS SPINAL SYSTEM

POLARIS SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K133746) manufactured by Biomet Spine (Aka Ebi, LLC). 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 11, 2014. Regulation: 8.