FX Shoulder Solutions, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
FX Shoulder Solutions, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FX V135 EASYTECH® Shoulder System
1
Total
1
Cleared
0
Denied
FX Shoulder Solutions, Inc. develops innovative shoulder prosthesis systems for surgical applications. The company specializes in Orthopedic solutions for shoulder arthroplasty, with a manufacturing facility in Addison, US.
The company has received 1 FDA 510(k) clearance from 1 total submission. FX Shoulder Solutions focuses exclusively on Orthopedic devices, with its first and latest clearance in 2026, demonstrating active regulatory engagement.
The cleared device portfolio includes solutions for both degenerative and trauma-related shoulder conditions. FX Shoulder Solutions maintains an active presence in shoulder surgery education and clinical advancement through international conferences and specialized training programs.
Explore the company's FDA 510(k) clearance details, device names, product codes, and approval dates in the database.
FDA 510(k) Regulatory Record - FX Shoulder Solutions, Inc.
1 devices