D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION is an FDA 510(k)-cleared medical device (K130497) manufactured by Linvatec Corporation D/B/A Conmed Linvatec. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2013. Regulation: 8.