K231708
- 510(k) number
- K231708
- Device name
- Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
- Applicant
- Axogen Corporation FL · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2023-10-12
- Date received
- 2023-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231708.pdf
Official FDA record: K231708
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.