FDA Registration
Active
🇨🇳 China
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SHANGHAI JPY ION-TECH CO., LTD.
- Registration Number
- 3004748528
- FEI Number
- 3004748528
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K111136
Owner / Operator
- Firm Name
- SHANGHAI JPY ION-TECH CO., LTD.
- Operator Number
- 9066119
- Address
- NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
- City
- SHANGHAI
- State
- CN-NOTA
- Postal Code
- 201707
- Country
- CN
US Agent
- Business Name
- MANTON BUSINESS & TECHNOLOGY SERVICES, LLC
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-06-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-06-27 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-06-27 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-06-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-06-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-06-27 |
Proprietary Names
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)