Fusion Innovations, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fusion Innovations, LLC - FDA 510(k) Cleared Devices
Recent clearances: SternaFuse Ti Fixation System, SternaFuse Fixation System
2
Total
2
Cleared
0
Denied
Fusion Innovations, LLC has 2 FDA 510(k) cleared medical devices. Based in Rock Hill, US.
Latest FDA clearance: Nov 2025. Active since 2022. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Fusion Innovations, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Rook Quality Systems and Kapstone Medical, LLC.
FDA 510(k) Regulatory Record - Fusion Innovations, LLC
2 devices