MINVASIVE SUTURE BONE FASTENER

MINVASIVE SUTURE BONE FASTENER is an FDA 510(k)-cleared medical device (K924034) 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 23, 1993. Regulation: 8.