Medical Device Manufacturer · SE , Goteborg

Ortoma AB - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared May 16, 2025

Orthopedic · 123d

Cleared Mar 11, 2024

Orthopedic · 237d

Cleared Sep 19, 2018

Ortoma Treatment Solution - OTS

Orthopedic · 110d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 30, 2026