FDA Registration
Active
🇫🇷 France
Exeter V40, 37.5mm, N1, L.205 fully tapered
Reg #: 3008556682
·
FEI: 3008556682
·
Expires 2025
Products
3
Proprietary Names
8
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- LISI MEDICAL ORTHOPAEDICS
- Registration Number
- 3008556682
- FEI Number
- 3008556682
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 203 BD de la Grande Delle, BP 8
- City
- HEROUVILLE ST CLAIR CEDEX Normandie
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K173499
Owner / Operator
- Firm Name
- LISI MEDICAL ORTHOPAEDICS
- Operator Number
- 10043163
- Address
- 203 BD de la Grande Delle, BP 8
- City
- HEROUVILLE ST CLAIR CEDEX
- State
- Normandie
- Postal Code
- 14201
- Country
- FR
- Correspondent
- GAELLE TRECHOT
US Agent
- Business Name
- LISI MEDICAL Remmele
- Contact Name
- Stephanie Potel
- Address
- 17701 198th Avenue NW
- City
- Big Lake
- State
- MN
- ZIP
- 55309
- Country
- US
- [email protected]
- Phone
- 763 2180593
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2018-07-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-07-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-07-05 |
Proprietary Names
Exeter V40, 37.5mm, N1, L.205 fully tapered
Exeter V40, 50mm, N1, L. 125mm
Exeter V40, 37.5mm, N1, L. 125mm
Exeter V40, 44mm, N1, L. 125mm
Orthinox 22.2mm/-2mm V40 Femoral Head
Exeter V40, 56mm, N1, L. 150mm
Orthinox 22.2mm/+3mm V40 Femoral Head
Exeter V40, 56mm,N2, L. 150mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)