Medline UNITE IM Fibula Implant

Medline UNITE IM Fibula Implant is an FDA 510(k)-cleared medical device (K220511) manufactured by Medline Industries, LP. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2022. Regulation: 8.