Fusion Innovations, LLC

FDA Regulatory Profile

Fusion Innovations, LLC appears in FDA public data with 0 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Nov 19, 2025.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252661SternaFuse Ti Fixation SystemNov 19, 2025
K202914SternaFuse Fixation SystemJan 26, 2022