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

Genesis Medical LLC
Free shipping on orders over $99 · 30-day returns
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 is an FDA 510(k)-cleared medical device (K043346) manufactured by Genesis Medical LLC. 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 30, 2005. Regulation: 8.