VariTrax Sternal CircumFixation System
K-Number: K232986 · 2024-01-30
ApplicantCircumfix Solutions, Inc.
Decision Date2024-01-30
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VariTrax Sternal CircumFixation System is a medical device manufactured by Circumfix Solutions, Inc.. It received FDA 510(k) clearance on 2024-01-30 under approval number K232986. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VariTrax Sternal CircumFixation System?
VariTrax Sternal CircumFixation System is a medical device that received FDA 510(k) clearance on 2024-01-30. It is manufactured by Circumfix Solutions, Inc.. The 510(k) number is K232986.
When was VariTrax Sternal CircumFixation System approved by the FDA?
VariTrax Sternal CircumFixation System received FDA 510(k) clearance on 2024-01-30, under approval number K232986.
What company makes VariTrax Sternal CircumFixation System?
VariTrax Sternal CircumFixation System is manufactured by Circumfix Solutions, Inc..
What is the FDA product code for VariTrax Sternal CircumFixation System?
The FDA product code for VariTrax Sternal CircumFixation System is JDQ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.