FDA Registration
Active
🇵🇱 Poland
SYNERGY
Reg #: 3009141957
·
FEI: 3009141957
·
Expires 2025
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Paragon Medical Siechnice
- Registration Number
- 3009141957
- FEI Number
- 3009141957
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Stanislawa Staszica 5
- City
- Siechnice Dolnoslaskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K123598
Owner / Operator
- Firm Name
- Paragon Medical
- Operator Number
- 9011072
- Address
- 8 Matchett Dr., --
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Stephane Langlois
US Agent
- Business Name
- Paragon Medical
- Contact Name
- Stephane Langlois
- Address
- 8 Matchett Dr
- City
- Pierceton
- State
- IN
- ZIP
- 46562
- Country
- US
- [email protected]
- Phone
- 435 5355456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-06-15 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-06-15 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2020-06-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2020-06-15 |
Proprietary Names
SYNERGY
POLARSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)