FDA Registration
Active
🇺🇸 United States
PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE)
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
- 510(k) Number
- K093695
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-11-28 |
Proprietary Names
PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE)
Establishment Types
Manufacture Medical Device