K252404
- 510(k) number
- K252404
- Device name
- Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
- Applicant
- Biomet Orthopedics IN · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-04-15
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K252404.pdf
Official FDA record: K252404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.