K231522
- 510(k) number
- K231522
- Device name
- EMPHASYS Dual Mobility System
- Applicant
- Depuy Ireland UC IE
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2024-02-15
- Date received
- 2023-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K231522.pdf
Official FDA record: K231522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.