K253624
- 510(k) number
- K253624
- Device name
- INHANCE Reverse Shoulder System
- Applicant
- Depuy Ireland UC IE
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-03-11
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253624.pdf
Official FDA record: K253624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.