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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Circumfix Solutions, Inc.. It received FDA 510(k) clearance on 2024-01-30 under 510(k) 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. The listed applicant is Circumfix Solutions, Inc.. The 510(k) number is K232986.

When did VariTrax Sternal CircumFixation System receive FDA 510(k) clearance?

VariTrax Sternal CircumFixation System received FDA 510(k) clearance on 2024-01-30, under 510(k) number K232986.

Who is the listed applicant for VariTrax Sternal CircumFixation System?

The FDA 510(k) record lists Circumfix Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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