ClearPoint Bone Screw Fiducials

ClearPoint Bone Screw Fiducials is an FDA 510(k)-cleared medical device (K233144) manufactured by ClearPoint Neuro, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2024. Regulation: 8.