K261016
- 510(k) number
- K261016
- Device name
- MSS - Humeral reverse liners extension
- Applicant
- Medacta International, SA CH
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-06-10
- Date received
- 2026-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261016.pdf
Official FDA record: K261016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.