BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medtronic Total Hip Arthroplasty System

    K Number: K183129 · Decision Jul 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    8
    Review Days
    255

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    Basic Information

    Device Name
    Medtronic Total Hip Arthroplasty System
    K Number
    K183129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Advanced Energy
    Date Received
    November 13, 2018
    Decision Date
    July 26, 2019
    Product Code
    LPH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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