FDA Registration
Active
🇺🇸 United States
Rejuvenate Monolithic HIP System
Reg #: 3000196378
·
FEI: 3000196378
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Polymer Corporation
- Registration Number
- 3000196378
- FEI Number
- 3000196378
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 35 Industrial Park Pl
- City
- Middletown
- State
- CT
- ZIP
- 06457
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082892
Owner / Operator
- Firm Name
- Polymer Corporation
- Operator Number
- 10087484
- Address
- 35 Industrial Park Place
- City
- Middletown
- State
- CT
- Postal Code
- 06457
- Country
- US
- Correspondent
- James Ryan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2023-03-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2023-03-05 |
Proprietary Names
Rejuvenate Monolithic HIP System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)