ELEOS Limb Salvage System featuring BIOGRIP

ELEOS Limb Salvage System featuring BIOGRIP is an FDA 510(k)-cleared medical device (K203090) 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 December 10, 2020. Regulation: 8.