FDA Registration
Active
🇫🇷 France
ACS® FB tibial trial adapter 6 15mm
Reg #: 3011274144
·
FEI: 3011274144
·
Expires 2025
Products
1
Proprietary Names
141
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
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 |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2017-04-11 |
Proprietary Names
ACS® FB tibial trial adapter 6 15mm
ACS® FB trial PE insert PS 3/10mm
ACS® FB tibial trial adapter 6 17,5mm
MK trial femoral spacer posterior 3/10mm
ACS® FB trial PE insert PS 5/12,5mm
MK trial femoral spacer distal ll/rm 3/5mm
ACS® FB trial PE insert 6/11,25mm
ACS® FB trial PE insert 3/13,75mm
MK trial femoral spacer distal ll/rm 2/5mm
ACS® FB trial PE insert SC 4/12,5mm
ACS® FB trial PE insert ultra 2/10mm
ACS® FB tibial trial spacer ll/rm 6/5mm
ACS® FB trial PE insert ultra 6 10mm
ACS® FB trial PE insert PS 3/12,5mm
MK trial femoral spacer posterior 5/5mm
MK trial femoral spacer distal rl/lm 6/5mm
MK trial femoral spacer distal ll/rm 2,5/10mm
ACS® FB tibial trial spacer rl/lm 2/10mm
ACS® FB tibial trial spacer ll/rm 2/5mm
ACS® FB tibial trial spacer ll/rm 2,5/10mm
ACS® FB tibial trial adapter 3 15mm
ACS® FB trial PE insert SC 6/10mm
ACS® FB tibial trial adapter 4 17,5mm
MK trial femoral spacer posterior 5/10mm
ACS® FB trial PE insert ultra 4 10mm
ACS® FB trial PE insert SC 5/10mm
ACS® FB tibial trial spacer rl/lm 6/5mm
ACS® FB trial PE insert PS 3/11,25mm
Salto Talaris Total Ankle Prosthesis
ACS® FB trial PE insert 4/11,25mm
ACS® FB tibial trial spacer ll/rm 5/10mm
ACS® FB trial PE insert PS 2/11,25mm
ACS® FB trial PE insert PS 4/11,25mm
MK trial femoral spacer posterior 2/5mm
ACS® FB trial PE insert PS 6/12,5mm
ACS® FB trial PE insert 4/13,75mm
ACS® FB tibial trial spacer ll/rm 2,5/5mm
ACS® FB tibial trial adapter 2 15mm
MK trial femoral spacer posterior 6/10mm
MK trial femoral spacer distal rl/lm 2/10mm
MK trial femoral spacer distal ll/rm 5/10mm
MK trial femoral spacer distal ll/rm 6/10mm
MK trial femoral spacer posterior 4/5mm
ACS® FB tibial trial adapter 2 17,5mm
ACS® FB trial PE insert SC 5/12,5mm
ACS® FB trial PE insert 2/13,75mm
ACS® FB trial PE insert SC 3/10mm
ACS® PE patella trial 26mm
MK trial femoral spacer posterior 2,5/5mm
ACS® FB trial PE insert PS 6/13,75mm
ACS® PE patella trial 35mm
ACS® FB tibial trial adapter 5 20mm
ACS® FB tibial trial adapter 5 17,5mm
MK trial femoral spacer distal rl/lm 2,5/5mm
ACS® FB tibial trial adapter 3 17,5mm
AGILON® XO trial glenoid sz. 1
MK trial femoral spacer distal rl/lm 4/10mm
ACS® FB trial PE insert PS 2/12,5mm
ACS® FB trial PE insert PS 2/13,75mm
ACS® FB tibial trial spacer ll/rm 3/5mm
MK trial femoral spacer distal ll/rm 3/10mm
AGILON® XO trial glenoid sz. 2
ACS® FB trial PE insert hyperflex 5/10mm
ACS® FB trial PE insert ultra 3 12,5mm
ACS® FB tibial trial spacer rl/lm 5/5mm
ACS® FB tibial trial spacer ll/rm 2/10mm
ACS® PE patella trial 29mm
ACS® FB trial PE insert 2/11,25mm
ACS® FB tibial trial adapter 6 20mm
ACS® FB tibial trial spacer rl/lm 2,5/10mm
ACS® FB tibial trial spacer rl/lm 3,5/10mm
AGILON® XO trial glenoid sz. 3
ACS® FB tibial trial spacer rl/lm 4/10mm
ACS® FB trial PE insert ultra 6 12,5mm
ACS® FB trial PE insert hyperflex 4/12,5mm
MK trial femoral spacer posterior 3/5mm
MK trial femoral spacer posterior 4/10mm
MK trial femoral spacer distal rl/lm 3/5mm
ACS® FB trial PE insert 3/11,25mm
ACS® FB tibial trial adapter 3 20mm
ACS® FB tibial trial spacer ll/rm 4/5mm
ACS® FB trial PE insert SC 4/10mm
ACS® FB trial PE insert 5/11,25mm
ACS® FB tibial trial spacer rl/lm 6/10mm
ACS® FB tibial trial adapter 4 20mm
MK trial femoral spacer distal ll/rm 2,5/5mm
MK trial femoral spacer distal ll/rm 6/5
ACS® PE patella trial 32mm
MK trial femoral spacer distal ll/rm 2/10mm
ACS® FB trial PE insert SC 2/10mm
MK trial femoral spacer posterior 6/5mm
ACS® FB trial PE insert PS 3/13,75mm
ACS® FB tibial trial spacer ll/rm 6/10mm
ACS® FB trial PE insert 6/13,75mm
ACS® FB tibial trial spacer rl/lm 4/5mm
ACS® FB trial PE insert PS 6/10mm
MK trial femoral spacer posterior 2/10mm
ACS® FB trial PE insert ultra 3 10mm
MK trial femoral spacer distal rl/lm 5/10mm
ACS® FB trial PE insert ultra 2 12,5mm
ACS® FB trial PE insert 5/13,75mm
ACS® FB tibial trial adapter 2 20mm
ACS® FB trial PE insert PS 4/13,75mm
ACS® FB trial PE insert hyperflex 3/10mm
MK trial femoral spacer posterior 2,5/10mm
ACS® FB tibial trial spacer ll/rm 5/5mm
ACS® FB trial PE insert PS 5/11,25mm
AGILON® XO trial glenoid sz. 4
ACS® FB tibial trial adapter 4 15mm
ACS® FB trial PE insert SC 6/12,5mm
ACS® FB tibial trial spacer ll/rm 4/10mm
MK trial femoral spacer distal rl/lm 4/5mm
ACS® FB trial PE insert PS 6/11,25mm
ACS® FB tibial trial spacer rl/lm 3/10mm
ACS® FB trial PE insert SC 3/12,5mm
ACS® FB trial PE insert PS 4/10mm
ACS® FB tibial trial adapter 5 15mm
ACS® FB trial PE insert ultra 5 10mm
MK trial femoral spacer distal ll/rm 4/10mm
MK trial femoral spacer distal rl/lm 5/5mm
MK trial femoral spacer distal ll/rm 4/5mm
ACS® FB trial PE insert ultra 4 12,5mm
ACS® FB trial PE insert SC 2/12,5mm
ACS® FB trial PE insert PS 2/10mm
ACS® FB tibial trial spacer rl/lm 2,5/5mm
MK trial femoral spacer distal rl/lm 2/5mm
ACS® FB trial PE insert PS 5/13,75mm
ACS® FB tibial trial spacer ll/rm 3,5/10mm
ACS® FB tibial trial spacer ll/rm 3/10mm
ACS® FB trial PE insert ultra 5 12,5mm
ACS® FB tibial trial spacer rl/lm 3/5mm
ACS® FB tibial trial spacer rl/lm 3,5/5mm
ACS® FB trial PE insert PS 4/12,5mm
MK trial femoral spacer distal rl/lm 3/10mm
MK trial femoral spacer distal rl/lm 6/10mm
MK trial femoral spacer distal rl/lm 2,5/10mm
ACS® FB tibial trial spacer rl/lm 5/10mm
ACS® FB tibial trial spacer rl/lm 2/5mm
ACS® FB tibial trial spacer ll/rm 3,5/5mm
ACS® FB trial PE insert PS 5/10mm
MK trial femoral spacer distal ll/rm 5/5mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)