K254154
- 510(k) number
- K254154
- Device name
- FX V135 EASYTECH® Shoulder System
- Applicant
- FX Shoulder Solutions, Inc. TX · US
- Product code
- PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Meta
- Decision date
- 2026-05-01
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K254154.pdf
Official FDA record: K254154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.