Ortoma AB is one of 119 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Ortoma AB has 4 FDA 510(k) cleared medical devices. Based in Goteborg, SE.
Latest FDA clearance: Jul 2026. 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, Msquared Associates, Inc. and Hogan Lovells US Llp.
FDA 510(k) Regulatory Record - Ortoma AB
4 devices