Medical Device Manufacturer · US , Rock Hill , SC

Fusion Innovations, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fusion Innovations, LLC Orthopedic ✕
2 devices
1-2 of 2
Cleared Nov 19, 2025
SternaFuse Ti Fixation System
K252661 · HRS
Orthopedic · 89d
Cleared Jan 26, 2022
SternaFuse Fixation System
K202914 · HRS
Orthopedic · 484d
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