FDA Registration
Active
🇺🇸 United States
Hip Stems
Reg #: 1529009
·
FEI: 1000149660
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- APS MATERIALS, INC.
- Registration Number
- 1529009
- FEI Number
- 1000149660
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4011 RIVERSIDE DR.
- City
- DAYTON
- State
- OH
- ZIP
- 45405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033313
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2014-12-29 |
Proprietary Names
Hip Stems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)