Tactoset Injectable Bone Substitute

Tactoset Injectable Bone Substitute is an FDA 510(k)-cleared medical device (K212083) manufactured by Anika Therapeutics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2021. Regulation: 8.