FDA 510(k) Applications Submitted by ClearPoint Neuro Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K233141 09/27/2023 SmartFrame OR ClearPoint Neuro Inc.
K233144 09/27/2023 ClearPoint Bone Screw Fiducials ClearPoint Neuro Inc.
K233155 09/27/2023 ClearPointer Optical Navigation Wand ClearPoint Neuro Inc.
K233243 09/28/2023 ClearPoint System (Software Version 2.2) ClearPoint Neuro Inc.
K233703 11/17/2023 Bone Anchor (NGS-BA-01) ClearPoint Neuro Inc.


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