K254128
- 510(k) number
- K254128
- Device name
- InSet Reverse Total Shoulder System
- Applicant
- Shoulder Innovations, Inc. MI · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-04-13
- Date received
- 2025-12-22
- 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: K254128.pdf
Official FDA record: K254128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.