510(k) K232986
K232986 is an FDA 510(k) premarket notification submitted by Circumfix Solutions, Inc. for the device "VariTrax Sternal CircumFixation System". The FDA issued a decision of Substantially Equivalent on January 30, 2024. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2024
- Date Received
- September 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type