FDA Registration
Active
🇺🇸 United States
CIRCUMFIX SOLUTIONS, INC
Reg #: 3027404764
·
FEI: 3027404764
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CIRCUMFIX SOLUTIONS, INC
- Registration Number
- 3027404764
- FEI Number
- 3027404764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 224 Grand Steeple Dr.
- City
- Collierville
- State
- TN
- ZIP
- 38017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232986
Owner / Operator
- Firm Name
- CircumFix Solutions, INC
- Operator Number
- 10089390
- Address
- 224 Grand Steeple Dr.
- City
- Collierville
- State
- TN
- Postal Code
- 38017
- Country
- US
- Correspondent
- Kenneth Richardson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-12-04 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-12-04 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2023-12-04 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-02-07 |
Proprietary Names
VariTrax Tensioning Instrument
VariTrax Sternal Template
VariTrax Cutting Instrument
VariTrax Sternal CircumFixation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility