K233703
- 510(k) number
- K233703
- Device name
- Bone Anchor (NGS-BA-01)
- Applicant
- ClearPoint Neuro, Inc. CA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2024-04-26
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233703.pdf
Official FDA record: K233703
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.