GO UNIVERSALK-WIRE FLUTED DRILL

GO UNIVERSALK-WIRE FLUTED DRILL is an FDA 510(k)-cleared medical device (K954543) manufactured by Genesis Orthopedics, Inc.. 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 7, 1995. Regulation: 8.