BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    E-XPE Acetabular Components and U-Motion II Acetabular Cup

    K Number: K172833 · Decision Jun 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    4
    Applicant Total
    40
    Review Days
    266

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    Basic Information

    Device Name
    E-XPE Acetabular Components and U-Motion II Acetabular Cup
    K Number
    K172833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United Orthopedic Corporation
    Date Received
    September 19, 2017
    Decision Date
    June 12, 2018
    Product Code
    OQI
    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
    OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

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