K250423
- 510(k) number
- K250423
- Device name
- mb-FIX Cranial Stabilization Systems
- Applicant
- Medical Bees GmbH DE
- Product code
- HBL — Holder, Head, Neurosurgical (Skull Clamp)
- Decision date
- 2025-11-06
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250423.pdf
Official FDA record: K250423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.