K233233
- 510(k) number
- K233233
- Device name
- EMPHASYS Femoral Stems
- Applicant
- Depuy Ireland UC IE
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2023-10-11
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K233233.pdf
Official FDA record: K233233
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.