K243977
- 510(k) number
- K243977
- Device name
- EMPHASYS Acetabular System
- Applicant
- Depuy Ireland UC IE
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-01-22
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243977.pdf
Official FDA record: K243977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.