ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS

ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS is an FDA 510(k)-cleared medical device (K073233) manufactured by Advanced Bio-Surfaces, 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 January 27, 2008. Regulation: 8.