INTEGRA TITANIUM BONE WEDGE

INTEGRA TITANIUM BONE WEDGE is an FDA 510(k)-cleared medical device (K131360) manufactured by Ascension Orthopedic. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2013. Regulation: 8.