FDA Registration
Active
🇸🇪 Sweden
Femoral Drilling Socket
Reg #: 9680235
·
FEI: 3002807188
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARTA PLAST AB
- Registration Number
- 9680235
- FEI Number
- 3002807188
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Antennvaegen 1
- City
- Tyresoe Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K221048
Owner / Operator
- Firm Name
- Arta Plast AB
- Operator Number
- 10051331
- Address
- Antennvaegen 1
- City
- Tyresoe
- State
- Stockholm
- Postal Code
- 13548
- Country
- SE
US Agent
- Business Name
- Arta Plast LLC
- Contact Name
- Steven Crees
- Address
- 5054 S Lakeshore Dr
- City
- Independence
- State
- MN
- ZIP
- 55359
- Country
- US
- [email protected]
- Phone
- 763 6399651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2023-03-31 |
Proprietary Names
Femoral Drilling Socket
Femoral Adjustment Socket
Patellar Adjustment Socket
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)