K233903
- 510(k) number
- K233903
- Device name
- Zeta Cranial Navigation System (ZNS131-US)
- Applicant
- Zeta Surgical, Inc. MA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2024-01-10
- Date received
- 2023-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233903.pdf
Official FDA record: K233903
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.