FDA Registration
Active
🇺🇸 United States
AxiaLIF+
Reg #: 3011302058
·
FEI: 3011302058
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TranS1
- Registration Number
- 3011302058
- FEI Number
- 3011302058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 32938 Tamina Rd., Suite 203
- City
- Magnolia
- State
- TX
- ZIP
- 77354
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050965
Owner / Operator
- Firm Name
- TranS1, LLC
- Operator Number
- 10048027
- Address
- 32938 Tamina Rd., Suite 203
- City
- Magnolia
- State
- TX
- Postal Code
- 77354
- Country
- US
- Correspondent
- Thomas A Hoghaug
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-04-06 |
Proprietary Names
AxiaLIF+
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility