CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) is an FDA 510(k)-cleared medical device (K013072) manufactured by Synthes. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2002. Regulation: 8.