PORE-SI BONE GRAFT SUBSTITUTE

PORE-SI BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K040082) manufactured by Apatech , Ltd.. 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 3, 2004. Regulation: 8.