K241059
- 510(k) number
- K241059
- Device name
- Pantheon Proximal Femur Reconstruction (PFR) System
- Applicant
- Adler Ortho S.P.A IT
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-01-13
- Date received
- 2024-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241059.pdf
Official FDA record: K241059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.