FDA Registration
Active
🇺🇸 United States
Class I instrument
Reg #: 2183449
·
FEI: 2183449
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHOFIX US LLC
- Registration Number
- 2183449
- FEI Number
- 2183449
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- ZIP
- 75056
- Country
- US
Owner / Operator
- Firm Name
- Orthofix US LLC
- Operator Number
- 10028162
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- Postal Code
- 75056
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 2015-11-09 |
Proprietary Names
Class I instrument
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility