ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is an FDA 510(k)-cleared medical device (K070751) manufactured by Isotis Orthobiologics, 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 October 14, 2007. Regulation: 8.