PLIF LITE AND TLIF LITE

PLIF LITE AND TLIF LITE is an FDA 510(k)-cleared medical device (K132907) manufactured by Sintea Plustek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 2014. Regulation: 8.