FDA Registration
Active
🇺🇸 United States
LEGION
Reg #: 1834331
·
FEI: 1000306340
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- PARAGON MEDICAL, INC.
- Registration Number
- 1834331
- FEI Number
- 1000306340
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Matchett Dr.
- City
- PIERCETON
- State
- IN
- ZIP
- 46562
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121393
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-18 |
Proprietary Names
LEGION
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)