FDA Registration
Active
🇨🇭 Switzerland
SYNTHES AFS
Reg #: 3009417901
·
FEI: 3009417901
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYNTHES GMBH
- Registration Number
- 3009417901
- FEI Number
- 3009417901
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Luzernstrasse 21
- City
- Zuchwil Solothurn
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K032534
Owner / Operator
- Firm Name
- SYNTHES GMBH / Synthes Produktions GmbH
- Operator Number
- 9071542
- Address
- 1301 Goshen Parkway
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2008-01-02 |
Proprietary Names
SYNTHES AFS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility