K233592
- 510(k) number
- K233592
- Device name
- BioPoly Radial Head Implant
- Applicant
- BioPoly, LLC IN · US
- Product code
- KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
- Decision date
- 2024-03-13
- Date received
- 2023-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K233592.pdf
Official FDA record: K233592
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.