FDA Registration
Active
🇺🇸 United States
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Reg #: 1529009
·
FEI: 1000149660
·
Expires 2025
Products
11
Proprietary Names
11
Establishment Types
1
Classifications
11
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
- K183553
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/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-07-15 |
Proprietary Names
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)