Bio2 CLM BG Bioactive Scaffold

Bio2 CLM BG Bioactive Scaffold is an FDA 510(k)-cleared medical device (K142463) manufactured by Bio2 Technologies, 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 December 17, 2014. Regulation: 8.