K253345
- 510(k) number
- K253345
- Device name
- JARVIS Diaphyseal Stem Standard
- Applicant
- FH Industrie FR
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-10-29
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253345.pdf
Official FDA record: K253345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.