OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is an FDA 510(k)-cleared medical device (K242494) manufactured by Riverpoint Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2024. Regulation: 8.