FDA Registration
Active
🇨🇳 China
Nautilus/Avatar
Reg #: 3012711663
·
FEI: 3012711663
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ZIBO DANTE CO, LTD
- Registration Number
- 3012711663
- FEI Number
- 3012711663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 206 Industry Yi Road, Huantai
- City
- Zibo City Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151196
Owner / Operator
- Firm Name
- Zibo Dante Co, LTD
- Operator Number
- 10058316
- Address
- No. 206 Industry Yi Road, Huantai
- City
- Zibo City
- State
- Shandong
- Postal Code
- 256400
- Country
- CN
- Correspondent
- Angela Batker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-02-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-02-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-02-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-02-06 |
Proprietary Names
Nautilus/Avatar
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)