FDA Registration
Active
🇺🇸 United States
RESTORATION MEDICAL POLYMERS
Reg #: 3015916578
·
FEI: 3015916578
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- RESTORATION MEDICAL POLYMERS
- Registration Number
- 3015916578
- FEI Number
- 3015916578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4474 East Park 30 Drive
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171054
Owner / Operator
- Firm Name
- Restoration Medical Polymers
- Operator Number
- 10078694
- Address
- 4474 East Park 30 Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Jordan Freedman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2020-11-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-11-02 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2020-11-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2020-11-02 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-11-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)