SPIDER SYSTEM KOLIBRI CEMENT NEEDLE

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE is an FDA 510(k)-cleared medical device (K130402) manufactured by Sintea Plustek, 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 March 31, 2013. Regulation: 8.