K242351
- 510(k) number
- K242351
- Device name
- Zeta Cranial Navigation System (ZNS131-US)
- Applicant
- Zeta Surgical, Inc. MA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2024-10-04
- Date received
- 2024-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242351.pdf
Official FDA record: K242351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.