INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER

INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K971922) 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 August 6, 1997. Regulation: 8.