ELEOS Limb Salvage System with BioGrip

ELEOS Limb Salvage System with BioGrip is an FDA 510(k)-cleared medical device (K203815) manufactured by Onkos Surgical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2021. Regulation: 8.