Data / Medical devices / United States / Circumfix Solutions, Inc
Circumfix Solutions, Inc: FDA-registered device maker in Collierville, TN, United States, 1 510(k) clearance
Circumfix Solutions, Inc is registered with the FDA (registration 3027404764) in Collierville, TN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027404764
- Address
- 224 Grand Steeple Dr., Collierville, TN, United States, 38017
- Owner or operator
- CircumFix Solutions, INC (10089390)
- Roles
- Specification developer
- First device listed
- December 4, 2023
- Registered through
- 2026
- Brand names listed
- VariTrax Cutting Instrument, VariTrax Sternal CircumFixation System, VariTrax Sternal Template, VariTrax Tensioning Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cerclage, Fixation | JDQ | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2024 | K232986 | VariTrax Sternal CircumFixation System | JDQ | Substantially Equivalent | Circumfix Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Cutting, Orthopedic
- All makers of Template
- All makers of Cerclage, Fixation
- All makers of Pliers, Surgical
Updated January 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.