K250420
- 510(k) number
- K250420
- Device name
- Helios Dura Regeneration Matrix
- Applicant
- Helios Biomedical, Inc. MA · US
- Product code
- GXQ — Dura Substitute
- Decision date
- 2025-05-14
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K250420.pdf
Official FDA record: K250420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.