Ortho-Design (Pty), Ltd. is one of 8 FDA 510(k) medical device manufacturers from South Africa in the dataset, ranked by real submission volume.
Ortho-Design (Pty), Ltd. - FDA 510(k) Cleared Devices
Recent clearances: VersaTap™ Suture Anchor (ADP050), VersaTap, VersaLat, DueLock, VersaTi, MiniTi
2
Total
2
Cleared
0
Denied
Ortho-Design (Pty), Ltd. has 2 FDA 510(k) cleared medical devices. Based in Pretoria, ZA.
Latest FDA clearance: Aug 2024. Active since 2021. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Ortho-Design (Pty), Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Jalex Medical as regulatory consultant.
FDA 510(k) Regulatory Record - Ortho-Design (Pty), Ltd.
2 devices