K252824
- 510(k) number
- K252824
- Device name
- Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
- Applicant
- Signature Orthopaedics Pty, Ltd. AU
- Product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Ce
- Decision date
- 2026-03-12
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252824.pdf
Official FDA record: K252824
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.