INNESIS PEEK TL CAGE

INNESIS PEEK TL CAGE is an FDA 510(k)-cleared medical device (K140577) manufactured by Bk Meditech, Co., Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 2014. Regulation: 8.