K241944
- 510(k) number
- K241944
- Device name
- AGILON® XO Shoulder Replacement System
- Applicant
- Implantcast GmbH DE
- Product code
- KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
- Decision date
- 2025-03-10
- Date received
- 2024-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241944.pdf
Official FDA record: K241944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.