K232986 is an FDA 510(k) clearance for the VariTrax Sternal CircumFixation System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Circumfix Solutions, Inc. (Collierville, US). The FDA issued a Cleared decision on January 30, 2024, 130 days after receiving the submission on September 22, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K232986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | January 30, 2024 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ - Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |