CONFIDENCE FENESTRATED INTRODUCER NEEDLE

CONFIDENCE FENESTRATED INTRODUCER NEEDLE is an FDA 510(k)-cleared medical device (K063067) manufactured by Disc-O-Tech Medical Technologies, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 2006. Regulation: 8.