FDA Registration
Active
🇨🇭 Switzerland
Jabil8683 (DK) - Expedium Verse Spine System
Reg #: 8043792
·
FEI: 3002808269
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
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
- K142185
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 |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-02-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-02-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-02-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-02-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-02-23 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-02-23 |
Proprietary Names
Jabil8683 (DK) - Expedium Verse Spine System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)