Fixated Asfora BULLET CAGE® (FABC)

Fixated Asfora BULLET CAGE® (FABC) is an FDA 510(k)-cleared medical device (K181591) manufactured by Medical Designs, 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 September 25, 2018. Regulation: 8.