Product areas
FDA product code distribution
Orthofix US, LLC
Country / Region:United States (US)
510(k) submissions
1
Filtered: OLO
Latest clearance
2025-10-31
Product codes
1
OLO
Cited as predicate
0
510(k) submissions
1 total · filtered by OLO
Showing 1–1
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K252088 | Firebird SI Navigation System | OLO | Class 2 | 2025-10-31 |
Company profile
- Canonical name
- Orthofix US, LLC
- Country / Region
- United States(US)
- Address
- 3451 Plano Pkwy. Lewisville, TX 75056
Predicate manufacturers
Companies whose devices this company cited as predicates
No predicate manufacturers found
This company has not cited predicate devices with known manufacturers yet
Citing manufacturers
Companies that cited this company's devices as predicates
No citing manufacturers yet
Other companies will appear here when they cite this company's devices as predicates