K240381
- 510(k) number
- K240381
- Device name
- CATALYSTEM Femoral Stems
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-06-27
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240381.pdf
Official FDA record: K240381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.