Orthofix US, LLC

FDA Regulatory Profile

Orthofix US, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 31, 2025.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Known Names

Orthofix Us, Orthofix U.S

Recent 510(k) Clearances

K-NumberDeviceDate
K252088Firebird SI Navigation SystemOct 31, 2025
K230252OFIX MIS AppSep 26, 2023
K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral FixFeb 11, 2022
K213951FORZA XP Expandable Spacer SystemJan 5, 2022