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510(k) Data Aggregation
K Number
K232986Device Name
VariTrax Sternal CircumFixation System
Manufacturer
CircumFix Solutions, Inc.
Date Cleared
2024-01-30
(130 days)
Product Code
JDQ, HRS
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
CircumFix Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Device Description
The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate. They are single-use devices provided in a sterile kit. The VariTrax bands are placed in peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum.
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