INNOVASIVE 8MM LIGAMENT FASTENER

INNOVASIVE 8MM LIGAMENT FASTENER is an FDA 510(k)-cleared medical device (K970316) 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 April 15, 1997. Regulation: 8.