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

Signus Medizintechnik GmbH
Free shipping on orders over $99 · 30-day returns
OVALTWIST PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K061577) manufactured by Signus Medizintechnik GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2006. Regulation: 8.