K250338
- 510(k) number
- K250338
- Device name
- MSS - Humeral reverse liners extension
- Applicant
- Medacta International S.A. CH
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-10-31
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250338.pdf
Official FDA record: K250338
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.