K232986
- 510(k) number
- K232986
- Device name
- VariTrax Sternal CircumFixation System
- Applicant
- Circumfix Solutions, Inc. TN · US
- Product code
- JDQ — Cerclage, Fixation
- Decision date
- 2024-01-30
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232986.pdf
Official FDA record: K232986
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.