K250644
- 510(k) number
- K250644
- Device name
- MSS - Monobloc stem
- Applicant
- Medacta International S.A. CH
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-02-03
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250644.pdf
Official FDA record: K250644
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.