FDA Registration
Active
🇨🇭 Switzerland
NEO Pedicle Screw System
Reg #: 3013546462
·
FEI: 3013546462
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NEO MEDICAL S.A.
- Registration Number
- 3013546462
- FEI Number
- 3013546462
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Route de Lausanne 157A
- City
- Villette (Lavaux) Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K202458
Owner / Operator
- Firm Name
- Neo Medical S.A.
- Operator Number
- 10054814
- Address
- Route de Lausanne 157A
- City
- Villette (Lavaux)
- State
- Vaud
- Postal Code
- 1096
- Country
- CH
- Correspondent
- Jonas Larsson
US Agent
- Business Name
- confinis USA Inc.
- Contact Name
- Alfred Lerch
- Address
- 600 Park Offices Drive Suite 300, Unit #50
- City
- Durham
- State
- NC
- ZIP
- 27709
- Country
- US
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-11-03 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-11-03 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2021-11-03 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2021-11-03 |
Proprietary Names
NEO Pedicle Screw System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility