TirboLOX-L Lumbar IBFD

TirboLOX-L Lumbar IBFD is an FDA 510(k)-cleared medical device (K180990) manufactured by Captiva Spine, 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 12, 2018. Regulation: 8.