Ortobio S.A. is one of 47 FDA 510(k) medical device manufacturers from Brazil in the dataset, ranked by real submission volume.
Ortobio S.A. - FDA 510(k) Cleared Devices
1
Total
1
Cleared
0
Denied
Ortobio S.A. has 1 FDA 510(k) cleared medical devices. Based in Maringá, BR.
Latest FDA clearance: May 2026. Active since 2026. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Ortobio S.A. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Pr Serviços Regulatórios Administrativos Ltda as regulatory consultant.
Ortobio S.A. — FDA 510(k) Products and Clearance History
1 devices