ORTOMA AB

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2615-2025Class IIOrtoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI cJuly 28, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K250086OTS HipMay 16, 2025
K232140OTS HipMarch 11, 2024
K181449Ortoma Treatment Solution - OTSSeptember 19, 2018