INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER

INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K944831) 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 31, 1995. Regulation: 8.