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

Aesculap Implant System, Inc.
Free shipping on orders over $99 · 30-day returns
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT is an FDA 510(k)-cleared medical device (K122783) manufactured by Aesculap Implant System, 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 October 29, 2013. Regulation: 8.