Medical Device Manufacturer · SE , Goteborg

Ortoma AB - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2018

Recent clearances: OTS Hip, OTS Hip, OTS Hip

4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ortoma AB Orthopedic ✕

4 devices
1-4 of 4
Cleared Jul 01, 2026
OTS Hip
K261852 · OLO
Orthopedic · 28d
Cleared May 16, 2025
OTS Hip
K250086 · OLO
Orthopedic · 123d
Cleared Mar 11, 2024
OTS Hip
K232140 · OLO
Orthopedic · 237d
Cleared Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449 · OLO
Orthopedic · 110d
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