NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit is an FDA 510(k)-cleared medical device (K143301) manufactured by Integrated Healing Technologies. 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 March 2, 2015. Regulation: 8.