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Dev4

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)October 10, 2025
K250251Eleganz Fusion Screw System (Fusion Screw System)June 13, 2025