IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA

IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA is an FDA 510(k)-cleared medical device (K983835) 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 March 14, 1999. Regulation: 8.