KMTI S141 Lumbar Interbody Fusion System

KMTI S141 Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K212070) manufactured by Kyocera Medical Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2021. Regulation: 8.