K232556
- 510(k) number
- K232556
- Device name
- DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
- Applicant
- Depuy Ireland UC IE
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2023-09-20
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232556.pdf
Official FDA record: K232556
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.