ORTHADAPT BIOIMPLANT

ORTHADAPT BIOIMPLANT is an FDA 510(k)-cleared medical device (K071065) manufactured by Pegasus Biologics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2007. Regulation: 8.