INNOVASIVE TIBIAL FASTENER

INNOVASIVE TIBIAL FASTENER is an FDA 510(k)-cleared medical device (K983056) 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 October 12, 1998. Regulation: 8.