K243678
- 510(k) number
- K243678
- Device name
- TalisMann Neuromodulation System
- Applicant
- Bioventus, LLC NC · US
- Product code
- GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief
- Decision date
- 2025-07-03
- Date received
- 2024-11-27
- 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: K243678.pdf
Official FDA record: K243678
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.