COLORADO THERAPEUTICS XENOGRAFT IMPLANT

COLORADO THERAPEUTICS XENOGRAFT IMPLANT is an FDA 510(k)-cleared medical device (K160181) manufactured by Colorado Therapeutics, LLC. 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 October 19, 2016. Regulation: 8.