Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Orthofix US, LLC

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

Total Devices5
Categories5
Latest Approval2025-10-31
TypeNumberDevice NameCodeDate
510(k) K252088 Firebird SI Navigation System OLO 2025-10-31 View
510(k) K230252 OFIX MIS App LLZ 2023-09-26 View
PMA P210035 Stimulator, bone growth, non-invasive LOF 2022-05-03 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 System KWQ 2022-02-11 View
510(k) K213951 FORZA XP Expandable Spacer System MAX 2022-01-05 View
↑