MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) is an FDA 510(k)-cleared medical device (K071375) 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 December 20, 2007. Regulation: 8.