K254003
- 510(k) number
- K254003
- Device name
- JARVIS Metaphyseal Stem
- Applicant
- FH Industrie FR
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-01-09
- Date received
- 2025-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K254003.pdf
Official FDA record: K254003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.