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Orthofix US, LLC

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories5
Latest FDA decision2025-10-31
TypeNumberDevice NameCodeDateActions
510(k) K252088 Firebird SI Navigation SystemOLO2025-10-31 View
PMA P210035 Stimulator, bone growth, non-invasiveLOF2025-03-21 View
510(k) K230252 OFIX MIS AppLLZ2023-09-26 View
510(k) K211712 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 SystemKWQ2022-02-11 View
510(k) K213951 FORZA XP Expandable Spacer SystemMAX2022-01-05 View
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