ClearPoint Bone Screw Fiducials
K-Number: K233144 · 2024-01-12
ApplicantClearPoint Neuro, Inc.
Decision Date2024-01-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearPoint Bone Screw Fiducials is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under approval number K233144. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearPoint Bone Screw Fiducials?
ClearPoint Bone Screw Fiducials is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K233144.
When was ClearPoint Bone Screw Fiducials approved by the FDA?
ClearPoint Bone Screw Fiducials received FDA 510(k) clearance on 2024-01-12, under approval number K233144.
What company makes ClearPoint Bone Screw Fiducials?
ClearPoint Bone Screw Fiducials is manufactured by ClearPoint Neuro, Inc..
What is the FDA product code for ClearPoint Bone Screw Fiducials?
The FDA product code for ClearPoint Bone Screw Fiducials is HAW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.