FDA Registration
Active
🇨🇳 China
Oxford PKS Cemented tibia, Alpha, Standard - LM Size D
Reg #: 3004748528
·
FEI: 3004748528
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
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
- PMA Number
- P010014
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 |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | NRA | Class 3 | Unknown | No | 2022-06-30 |
Proprietary Names
Oxford PKS Cemented tibia, Alpha, Standard - LM Size D
Oxford PKS Cemented tibia, Alpha, Standard - LM Size C
Oxford PKS Cemented tibia, Alpha, Standard - LM Size AA
X-LARGE FEMORAL IMPLANT
Oxford PKS Cemented tibia, Alpha, Standard - RM Size A
Oxford PKS Cemented tibia, Alpha, Standard - LM Size E
X-SMALL FEMORAL IMPLANT
MEDIUM FEMORAL IMPLANT
Oxford PKS Cemented tibia, Alpha, Standard - RM Size E
SMALL FEMORAL IMPLANT
Oxford PKS Cemented tibia, Alpha, Standard - RM Size C
Oxford PKS Cemented tibia, Alpha, Standard - LM Size B
Oxford PKS Cemented tibia, Alpha, Standard - LM Size A
Oxford PKS Cemented tibia, Alpha, Standard - RM Size F
Oxford PKS Cemented tibia, Alpha, Standard - RM Size AA
Oxford PKS Cemented tibia, Alpha, Standard - RM Size D
Oxford PKS Cemented tibia, Alpha, Standard - LM Size F
LARGE FEMORAL IMPLANT
Oxford PKS Cemented tibia, Alpha, Standard - RM Size B
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)