KINEMAX PLUS TIBIAL SPACERS

KINEMAX PLUS TIBIAL SPACERS is an FDA 510(k)-cleared medical device (K964951) 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 February 23, 1997. Regulation: 8.