INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER

INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K954338) 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 March 20, 1996. Regulation: 8.