FDA Registration
Active
🇺🇸 United States
Xstim Spine Fusion Stimulator
Reg #: 3030686063
·
FEI: 3030686063
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XSTIM INC.
- Registration Number
- 3030686063
- FEI Number
- 3030686063
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1231 Greenway Dr Ste 260
- City
- Irving
- State
- TX
- ZIP
- 75038
- Country
- US
Regulatory Submissions
- PMA Number
- P230025
Owner / Operator
- Firm Name
- Xstim Inc.
- Operator Number
- 10090468
- Address
- 1231 Greenway Dr., Suite 260
- City
- Irving
- State
- TX
- Postal Code
- 75038
- Country
- US
- Correspondent
- John Oldham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 3 | Unknown | No | 2024-04-02 |
Proprietary Names
Xstim Spine Fusion Stimulator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility