INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER

INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER is an FDA 510(k)-cleared medical device (K983560) manufactured by Innovasive Devices, 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 January 27, 1999. Regulation: 8.