FDA Registration
Active
🇫🇷 France
SMR Stemless Anatomic
Reg #: 3011274144
·
FEI: 3011274144
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WESTLAKE PLASTICS EUROPE
- Registration Number
- 3011274144
- FEI Number
- 3011274144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 rue de Maestricht
- City
- TOURCOING Nord
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K221758
Owner / Operator
- Firm Name
- WESTLAKE PLASTICS EUROPE
- Operator Number
- 10048274
- Address
- 2 rue de Maestricht
- City
- TOURCOING
- State
- Nord
- Postal Code
- 59200
- Country
- FR
US Agent
- Business Name
- Westlake Plastics Company
- Contact Name
- Yared Mengistu
- Address
- 490 W. Lenni Road
- City
- Lenni
- State
- PA
- ZIP
- 19052
- Country
- US
- [email protected]
- Phone
- 610 4591000 ext. 2326
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-12-23 |
Proprietary Names
SMR Stemless Anatomic
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)