IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS

IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS is an FDA 510(k)-cleared medical device (K982302) manufactured by Implex 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 July 30, 1998. Regulation: 8.