K240278
- 510(k) number
- K240278
- Device name
- Full Wedge Lateralized and Augmented Baseplates
- Applicant
- Fx Shoulder USA, Inc. TX · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2024-05-15
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K240278.pdf
Official FDA record: K240278
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.