INNOVASIVE DEVICES ROTATOR CUFF FASTENER

INNOVASIVE DEVICES ROTATOR CUFF FASTENER is an FDA 510(k)-cleared medical device (K951565) 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 September 7, 1995. Regulation: 8.