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510(k) Data Aggregation

    K Number
    K253423

    Validate with FDA (Live)

    Device Name
    ToeJack MIS Bunion System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2025-11-18

    (54 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K211650,K181872,K172178
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

    Device Description

    The ToeJack MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and locking 3.0mm diameter titanium screws that provide fixation for the first metatarsal in the correction of a bunion. Specifically, the plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the proximal shaft with 2 screw fixation and extramedullary medial insertion of the 2 distal screws. Further, the device is provided with a screw targeting insertion guide.

    AI/ML Overview

    N/A

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