FDA Registration
Active
🇺🇸 United States
Z1 Hip System
Reg #: 1219213
·
FEI: 1219213
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Marox Corporation
- Registration Number
- 1219213
- FEI Number
- 1219213
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 373 WHITNEY AVE.
- City
- Holyoke
- State
- MA
- ZIP
- 01040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233476
Owner / Operator
- Firm Name
- Paragon Medical
- Operator Number
- 1219213
- Address
- 8 Matchett Drive, --
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Jim F Rogers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2024-05-10 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-05-10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-05-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-05-10 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-05-10 |
Proprietary Names
Z1 Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)