KINEMATIC ROTATING HINGE TOTAL KNEE PR.

KINEMATIC ROTATING HINGE TOTAL KNEE PR. is an FDA 510(k)-cleared medical device (K811630) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 1981. Regulation: 8.