FDA Registration
Active
🇺🇸 United States
X-STOP® Interspinous Spacer Titanium
Reg #: 3003120897
·
FEI: 3003120897
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Registration Number
- 3003120897
- FEI Number
- 3003120897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4340 Swinnea Road
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- PMA Number
- P040001
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2008-02-12 |
Proprietary Names
X-STOP® Interspinous Spacer Titanium
Establishment Types
Manufacture Medical Device