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

Hogan Lovells US LLP
Free shipping on orders over $99 · 30-day returns
CALYPSO SYSTEM is an FDA 510(k)-cleared medical device (K120564) manufactured by Hogan Lovells US LLP. 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 15, 2012. Regulation: 8.