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510(k) Data Aggregation

    K Number
    K251643
    Device Name
    Synchfix EVT
    Manufacturer
    Wright Medical Technology, Inc (Stryker Corporation)
    Date Cleared
    2025-10-29

    (153 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K170249
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synchfix™ EVT is intended for soft tissue and bone fixation for ankle syndesmosis disruptions with or without ankle fractures and as an adjunct in connection with hardware for ankle fractures such as Weber B, Weber C and Maisonneuve in adult and adolescent patient populations.

    Device Description

    The subject device, Synchfix™ EVT, is a sterile, single-use, suture-button system intended to stabilize syndesmotic disruptions in the ankle. The subject system consists of a UHMWPE suture tensioned between two titanium alloy buttons and single use instruments to assist in implantation, including a pre-loaded inserter.

    AI/ML Overview

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