INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER

INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K981193) 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 June 15, 1998. Regulation: 8.