K231526
- 510(k) number
- K231526
- Device name
- CORAIL Cemented Femoral Stem
- Applicant
- Depuy Ireland UC IE
- Product code
- KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Ceme
- Decision date
- 2023-12-19
- Date received
- 2023-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231526.pdf
Official FDA record: K231526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.