K253663
- 510(k) number
- K253663
- Device name
- Zeta Navigation System
- Applicant
- Zeta Surgical, Inc. MA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2026-05-01
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253663.pdf
Official FDA record: K253663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.