K233368
- 510(k) number
- K233368
- Device name
- Allograft Delivery Device (OFAC-C)
- Applicant
- Bioventus, LLC NC · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2024-06-25
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233368.pdf
Official FDA record: K233368
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.