Bone Anchor (NGS-BA-01)
K-Number: K233703 · 2024-04-26
ApplicantClearPoint Neuro, Inc.
Decision Date2024-04-26
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Bone Anchor (NGS-BA-01) is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-04-26 under approval number K233703. 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 Bone Anchor (NGS-BA-01)?
Bone Anchor (NGS-BA-01) is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K233703.
When was Bone Anchor (NGS-BA-01) approved by the FDA?
Bone Anchor (NGS-BA-01) received FDA 510(k) clearance on 2024-04-26, under approval number K233703.
What company makes Bone Anchor (NGS-BA-01)?
Bone Anchor (NGS-BA-01) is manufactured by ClearPoint Neuro, Inc..
What is the FDA product code for Bone Anchor (NGS-BA-01)?
The FDA product code for Bone Anchor (NGS-BA-01) 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.