FDA Registration
Active
🇨🇳 China
G7 PPSLTDACETSHELL 42A
Reg #: 3020282716
·
FEI: 3020282716
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- APS Materials Suzhou
- Registration Number
- 3020282716
- FEI Number
- 3020282716
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building # 2, Emerging Industrial Square, 78 Xinglin Street, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K121874
Owner / Operator
- Firm Name
- APS Materials, Inc
- Operator Number
- 9023611
- Address
- 4011 Riverside Dr, Dayton OH
- City
- Dayton
- State
- OH
- Postal Code
- 45405
- Country
- US
- Correspondent
- Chris Page
US Agent
- Business Name
- APS MATERIALS, INC
- Contact Name
- Christopher Page
- Address
- 4011 RIVERSIDE DR., --
- City
- Dayton
- State
- OH
- ZIP
- 45405
- Country
- US
- [email protected]
- Phone
- 937 2786547 ext. 249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-12-13 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-12-13 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2022-12-13 |
Proprietary Names
G7 PPSLTDACETSHELL 42A
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)