FDA Registration
Active
🇨🇳 China
APS Materials Suzhou
Reg #: 3020282716
·
FEI: 3020282716
·
Expires 2026
Products
22
Proprietary Names
10
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- APS Materials Suzhou
- Registration Number
- 3020282716
- FEI Number
- 3020282716
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building # 2, Emerging Industrial Square, 78 Xinglin Street, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 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 | KWZ | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 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 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2022-12-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-06-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-06-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-06-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-06-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-06-29 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2022-12-13 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2022-12-13 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2021-06-29 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2021-06-29 |
Proprietary Names
TPRLC 133 FP TYPE1 PPS
K091797
K031655
G7 PPSLTDACETSHELL 42A
K043151
K113174
K112555
K182928
G7 Finned Acetabular Shell
K042025
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)