FDA Registration
Active
🇺🇸 United States
Paragon Medical - Dayton
Reg #: 1000200989
·
FEI: 1000200989
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Paragon Medical - Dayton
- Registration Number
- 1000200989
- FEI Number
- 1000200989
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4201 Little York Rd
- City
- Dayton
- State
- OH
- ZIP
- 45414
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230831
Owner / Operator
- Firm Name
- Paragon Medical Inc.
- Operator Number
- 10043017
- Address
- 8 Matchett Dr.
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- James F Rogers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-08-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)