K250571
- 510(k) number
- K250571
- Device name
- CATALYSTEM Femoral Stems
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-03-28
- Date received
- 2025-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250571.pdf
Official FDA record: K250571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.