K250893
- 510(k) number
- K250893
- Device name
- Ball Joint Guide Array (66295)
- Applicant
- Bayer Medical Care, Inc. PA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-09-04
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K250893.pdf
Official FDA record: K250893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.