BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    World Hip Stem, World Cup, World Liner

    K Number: K201278 · Decision Sep 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    157
    Applicant Total
    27
    Review Days
    131

    Basic Information

    Device Name
    World Hip Stem, World Cup, World Liner
    K Number
    K201278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signature Orthopaedics Pty Ltd.
    Date Received
    May 13, 2020
    Decision Date
    September 21, 2020
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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