DARWIN KNEE SYSTEM (TC3)

DARWIN KNEE SYSTEM (TC3) is an FDA 510(k)-cleared medical device (K952830) manufactured by Johnson & Johnson Professionals, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 1996. Regulation: 8.