FDA Registration
Active
🇺🇸 United States
Polymer Corporation
Reg #: 3000196378
·
FEI: 3000196378
·
Expires 2026
Products
10
Proprietary Names
19
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Polymer Corporation
- Registration Number
- 3000196378
- FEI Number
- 3000196378
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35 Industrial Park Pl
- City
- Middletown
- State
- CT
- ZIP
- 06457
- Country
- US
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 |
|---|---|---|---|---|---|
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | 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, Hemi-, Femoral, Metal | KWL | 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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 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 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2023-03-05 |
Proprietary Names
Osteonics Universal Distal Cement Plug
Howmedica Osteonics Restoration HA Hip Stem
Osteonics Primary Secur-Fit Plus HIP Stems
Osteonics Restoration Monolithic II Slotted HIP Stem Series
Osteonics Omnifit HA HIP Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics Primary Secur-Fit Plus HIP Stems
Rejuvenate Monolithic HIP System
PT II Distal Cement Spacer
Osteonics Omnifit AD-HA Hip Stem Series
Omnifit M-HA HIP Stem Series
Secur-Fit Max and Plus Max HIP Stems
Accolade C Femoral Component
Osteonics Restoration Monolithic II HIP Stem Series
Osteonics Restoration HA HIP Stems
Osteonics Restoration Monolithic II Hip Stem Series
Rejuvenate Monolithic Size 4 HIP Stem
Accolade HFX Femoral Stem
Proximal Cement Spacer
Omnifit II EPF HIP Stem Series
Osteonics (R) Restoration Monolithic II Hip Stem Series
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)