FDA Registration
Active
🇺🇸 United States
EUROPA Pedicle Screw System
Reg #: 3014655115
·
FEI: 3014655115
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIRUS, LLC
- Registration Number
- 3014655115
- FEI Number
- 3014655115
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1755 W Oak Parkway, Suite 100
- City
- Marietta
- State
- GA
- ZIP
- 30062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182970
Owner / Operator
- Firm Name
- MiRus, LLC
- Operator Number
- 10059692
- Address
- 1755 West Oak Parkway, Suite 100
- City
- Marietta
- State
- GA
- Postal Code
- 30062
- Country
- US
- Correspondent
- Jordan Bauman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-02-12 |
Proprietary Names
EUROPA Pedicle Screw System
Establishment Types
Manufacture Medical Device