Bone Anchor (NGS-BA-01)

Bone Anchor (NGS-BA-01) is an FDA 510(k)-cleared medical device (K233703) 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 April 25, 2024. Regulation: 8.