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510(k) Data Aggregation

    K Number
    K260291

    Validate with FDA (Live)

    Device Name
    Vortex5 Tailor's Bunion Correction System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    13 - 21
    Reference & Predicate Devices
    K182949,K171558,K202657
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age).

    Device Description

    The Vortex5 Tailor's Bunion Correction System is a single-use bone Correction device intended to be permanently implanted. The system consists of an additively manufactured titanium alloy plate and machined screws that provide correction for 5th metatarsal osteotomies for the correction of Tailor's Bunion.

    AI/ML Overview

    N/A

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