K252516
- 510(k) number
- K252516
- Device name
- N22 EZ Glenosphere
- Applicant
- Shoulder Innovations, Inc. MI · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-01-15
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252516.pdf
Official FDA record: K252516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.