K250450
- 510(k) number
- K250450
- Device name
- Coated hip implants
- Applicant
- Medacta International S.A. CH
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-09-19
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K250450.pdf
Official FDA record: K250450
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.