INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE

INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE is an FDA 510(k)-cleared medical device (K970423) 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 April 29, 1997. Regulation: 8.