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

Medtronic Sofamor Danek USA, Inc.
Free shipping on orders over $99 · 30-day returns
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK is an FDA 510(k)-cleared medical device (K010528) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2001. Regulation: 8.