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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) 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. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233703.

When did Bone Anchor (NGS-BA-01) receive FDA 510(k) clearance?

Bone Anchor (NGS-BA-01) received FDA 510(k) clearance on 2024-04-26, under 510(k) number K233703.

Who is the listed applicant for Bone Anchor (NGS-BA-01)?

The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Anchor (NGS-BA-01)?

The FDA product code for Bone Anchor (NGS-BA-01) is HAW.

Other records listing ClearPoint Neuro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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.

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