Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Conformis, Inc.
Free shipping on orders over $99 · 30-day returns
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS is an FDA 510(k)-cleared medical device (K080936) manufactured by Conformis, 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 May 11, 2008. Regulation: 8.