FDA Registration
Active
🇺🇸 United States
FIXAL Acetabular Cup System
Reg #: 3010020754
·
FEI: 3010020754
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEXT ORTHOSURGICAL
- Registration Number
- 3010020754
- FEI Number
- 3010020754
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3270 Corporate Vw Ste A
- City
- Vista
- State
- CA
- ZIP
- 92081
- Country
- US
Owner / Operator
- Firm Name
- Next Orthosurgical
- Operator Number
- 10042957
- Address
- 3270 Corporate View, Suite A
- City
- Vista
- State
- CA
- Postal Code
- 92081
- Country
- US
- Correspondent
- Misty Calkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-04-04 |
Proprietary Names
FIXAL Acetabular Cup System
NEX-Fit Tapered Wedge Femoral Stem
Establishment Types
Manufacture Device in the United States for Export Only