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    K Number
    K161048
    Device Name
    Conventus Orthopaedics Ulna Fixation System
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Date Cleared
    2016-07-26

    (103 days)

    Product Code
    HRS,HSB
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000684,K073402,K102689,K131552,K151379
    Why did this record match?
    Device Name :

    Conventus Orthopaedics Ulna Fixation System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

    Device Description

    The Conventus Orthopaedics Ulna Fixation System is an intramedullary device intended for distal and proximal ulna fractures. The Ulna Fixation System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.

    AI/ML Overview

    This document is a 510(k) summary for the Conventus Orthopaedics Ulna Fixation System. It does not describe a study involving an AI/CADe/CADx device and human readers. Instead, it describes a medical device for fracture fixation and preclinical testing done to prove substantial equivalence to predicate devices. Therefore, I cannot extract the information requested as it is not present in the provided text.

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