K252411
- 510(k) number
- K252411
- Device name
- JARVIS Glenoid Reverse Shoulder Prosthesis
- Applicant
- FH Industrie FR
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-08-28
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252411.pdf
Official FDA record: K252411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.