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510(k) Data Aggregation

    K Number
    K014154
    Device Name
    VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00
    Manufacturer
    VILEX, INC.
    Date Cleared
    2002-03-18

    (90 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K991151,K991197
    Predicate For
    K063298,K120493,K124027,K131722,K133035,K143039,K150693,K150871,K160174,K161894,K163489,K173286,K180753,K182949,K200914,K221342,K250304
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the request about the acceptance criteria and the study that proves the device meets them. The document is a clearance letter from the FDA for a medical device (Vilex/Duval/Orthex Cannulated Bone Screw Double Thread) and outlines regulatory information and an "Indications for Use" statement. It does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or comparative effectiveness studies.

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