Uni-FuZe-P Bone Putty

Uni-FuZe-P Bone Putty is an FDA 510(k)-cleared medical device (K201781) manufactured by Zavation Medical Products, LLC. 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 27, 2020. Regulation: 8.