K230794
- 510(k) number
- K230794
- Device name
- Rebuilder Nerve Guidance Conduit
- Applicant
- Celestray Biotech Company, LLC., MD · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2024-01-29
- Date received
- 2023-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K230794.pdf
Official FDA record: K230794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.