Sorrento Bone Graft Substitute

Sorrento Bone Graft Substitute is an FDA 510(k)-cleared medical device (K191074) manufactured by Xenco Medical, 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 September 26, 2019. Regulation: 8.