FDA Registration
Active
🇨🇳 China
PINN SECTOR W/GRIPTION 48MM
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
10
Proprietary Names
40
Establishment Types
1
Classifications
10
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
- K231873
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2025-03-05 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-03-05 |
Proprietary Names
PINN SECTOR W/GRIPTION 48MM
PINN MULTIHOLE W/GRIPTION 56MM
PINN MULTIHOLE W/GRIPTION 66MM
PINN MULTIHOLE W/GRIPTION 62MM
PINN 100 W/GRIPTION 50MM
PINN SECTOR W/GRIPTION 62MM
PINN MULTIHOLE W/GRIPTION 58MM
PINN 100 W/GRIPTION 46MM
PINN MULTIHOLE W/GRIPTION 64MM
PINN MULTIHOLE W/GRIPTION 54MM
PINN BANTAM W/GRIPTION 42MM
PINN 100 W/GRIPTION 60MM
PINN BANTAM W/GRIPTION 40MM
PINN SECTOR W/GRIPTION 66MM
PINN SECTOR W/GRIPTION 54MM
PINN BANTAM W/GRIPTION 44MM
PINN 100 W/GRIPTION 54MM
PINN SECTOR W/GRIPTION 56MM
PINN 100 W/GRIPTION 52MM
PINN BANTAM W/GRIPTION 46MM
PINN SECTOR W/GRIPTION 58MM
PINN 100 W/GRIPTION 58MM
PINN MULTIHOLE W/GRIPTION 48MM
PINN 100 W/GRIPTION 44MM
PINN 100 W/GRIPTION 48MM
PINN SECTOR W/GRIPTION 60MM
PINN 100 W/GRIPTION 56MM
PINN MULTIHOLE W/GRIPTION 52MM
PINN MULTIHOLE W/GRIPTION 68MM
PINN 100 W/GRIPTION 62MM
PINN MULTIHOLE W/GRIPTION 72MM
PINN BANTAM W/GRIPTION 38MM
PINN SECTOR W/GRIPTION 50MM
PINN MULTIHOLE W/GRIPTION 50MM
PINN 100 W/GRIPTION 64MM
PINN MULTIHOLE W/GRIPTION 60MM
PINN 100 W/GRIPTION 66MM
PINN MULTIHOLE W/GRIPTION 70MM
PINN SECTOR W/GRIPTION 64MM
PINN SECTOR W/GRIPTION 52MM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)