FDA Registration
Active
🇺🇸 United States
Paragon Medical Inc.
Reg #: 1000517406
·
FEI: 1000517406
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
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
- K051735
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-01-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)