Orthofix US, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthofix US, LLC - FDA 510(k) Cleared Devices
Recent clearances: Firebird SI Navigation System, OFIX MIS App, 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
4
Total
4
Cleared
0
Denied
Orthofix US, LLC has 4 FDA 510(k) cleared medical devices. Based in Lweisville, US.
Latest FDA clearance: Oct 2025. Active since 2022. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Orthofix US, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orthofix US, LLC
4 devices