K250834
- 510(k) number
- K250834
- Device name
- Zimmer Biomet Ceramic Heads (22.2mm diameter)
- Applicant
- Zimmer Biomet IN · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-04-18
- Date received
- 2025-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250834.pdf
Official FDA record: K250834
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.