FDA Registration
Active
🇨🇳 China
G7 FINNED 4 HOLE SHELL 68I
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
8
Proprietary Names
14
Establishment Types
1
Classifications
8
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
- K142746
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 |
|---|---|---|---|---|---|
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2022-08-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-08-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-08-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-08-29 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-08-29 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-08-29 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2022-08-29 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-08-29 |
Proprietary Names
G7 FINNED 4 HOLE SHELL 68I
G7 FINNED 4 HOLE SHELL 56F
G7 FINNED 3 HOLE SHELL 48C
G7 FINNED 4 HOLE SHELL 54F
G7 FINNED 4 HOLE SHELL 60G
G7 FINNED 3 HOLE SHELL 46B
G7 FINNED 3 HOLE SHELL 52E
G7 FINNED 4 HOLE SHELL 62H
G7 FINNED 3 HOLE SHELL 42A
G7 FINNED 4 HOLE SHELL 66I
G7 FINNED 3 HOLE SHELL 50D
G7 FINNED 4 HOLE SHELL 64H
G7 FINNED 3 HOLE SHELL 44A
G7 FINNED 4 HOLE SHELL 58G
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)