FDA Registration
Active
🇺🇸 United States
Zimmer Nexel Total Elbow
Reg #: 1834331
·
FEI: 1000306340
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K123862
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, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2018-06-21 |
Proprietary Names
Zimmer Nexel Total Elbow
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)