FDA Registration
Active
🇺🇸 United States
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
Reg #: 2183449
·
FEI: 2183449
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
Regulatory Submissions
- 510(k) Number
- K142152
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2017-04-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-04-24 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2017-04-24 |
Proprietary Names
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility