FDA Registration
Active
🇺🇸 United States
Smith and Nephew
Reg #: 3021008900
·
FEI: 3021008900
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ARVATO USA LLC
- Registration Number
- 3021008900
- FEI Number
- 3021008900
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071160
Owner / Operator
- Firm Name
- Arvato USA LLC
- Operator Number
- 10082727
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- Postal Code
- 38118
- Country
- US
- Correspondent
- Raymundo Gutierrez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-10-19 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-10-19 |
Proprietary Names
Smith and Nephew
Establishment Types
Repack or Relabel Medical Device