Establishment registration
ORTHOFIX US LLC
FDA establishment registration 2183449 · Lewisville, US
Key facts
| Registration number | 2183449 |
|---|---|
| Establishment name | ORTHOFIX US LLC |
| Owner/operator | Orthofix US LLC |
| Owner/operator number | 10028162 |
| FEI number | 2183449 |
| Address | 3451 Plano Parkway |
| City | Lewisville |
| State | TX |
| Country | US |
| Registration valid through | 2026 |
| Product codes listed | FMF, FSM, FTY, FWZ, FZO, FZS, FZT, FZX, FZY, GAD, GAH, GCZ, GDG, GDH, GDI, GDW, GDZ, GEA, GEF, GEG, HAO, HRR, HRS, HRX, HSB, HTC, HTD, HTJ, HTO, HTQ and 65 more |
| Device classes | 1, 2, 3 |
At a glance
- 100–999 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- 10–99 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database