POLARIS SPINAL SYSTEM -TRANSLATION SCREW

POLARIS SPINAL SYSTEM -TRANSLATION SCREW is an FDA 510(k)-cleared medical device (K140123) manufactured by 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 April 23, 2014. Regulation: 8.