K253363
- 510(k) number
- K253363
- Device name
- NeuroSpan Bridge
- Applicant
- Auxilium Biotechnologies, Inc. MI · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2026-01-17
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253363.pdf
Official FDA record: K253363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.