Ortoma AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Ortoma AB - FDA 510(k) Cleared Devices
Recent clearances: OTS Hip, OTS Hip, Ortoma Treatment Solution - OTS
3
Total
3
Cleared
0
Denied
Ortoma AB has 3 FDA 510(k) cleared medical devices. Based in Goteborg, SE.
Latest FDA clearance: May 2025. Active since 2018. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Ortoma AB Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells, LLC and Msquared Associates, Inc..
FDA 510(k) Regulatory Record - Ortoma AB
3 devices