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510(k) K232986

VariTrax Sternal CircumFixation System by Circumfix Solutions, Inc. — Product Code JDQ

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

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