AccuFill Bone Substitute Material

AccuFill Bone Substitute Material is an FDA 510(k)-cleared medical device (K190814) manufactured by Zimmer Knee Creations. 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 9, 2019. Regulation: 8.