BIOROC EZ SUTURE BONE FASTENER

BIOROC EZ SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K973381) 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 February 17, 1998. Regulation: 8.