FDA Registration
Active
🇺🇸 United States
Paragon Medical Inc.
Reg #: 1000517406
·
FEI: 1000517406
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Paragon Medical Inc.
- Registration Number
- 1000517406
- FEI Number
- 1000517406
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 125 W 1000 S
- City
- Smithfield
- State
- UT
- ZIP
- 84335
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202716
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, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2022-05-11 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)