FDA Registration
Active
🇨🇭 Switzerland
ZimmerGmbH8803 (DK) - Anatomical Shoulder Domelock®
Reg #: 8043792
·
FEI: 3002808269
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Synergy Health Daniken AG
- Registration Number
- 8043792
- FEI Number
- 3002808269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HOGENWEIDSTRASSE 6
- City
- Daniken Solothurn
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K160085
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-02-17 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-02-17 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-02-17 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-02-17 |
Proprietary Names
ZimmerGmbH8803 (DK) - Anatomical Shoulder Domelock®
ZimmerGmbH8803 (DK) - Anatomical Shoulder
ZimmerGmbH8803 (DK) - Anatomical Shoulder Domelock®
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)