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

    Distal Centralizers

    K Number: K193546 · Decision Sep 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    441
    Review Days
    280

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    Basic Information

    Device Name
    Distal Centralizers
    K Number
    K193546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    December 20, 2019
    Decision Date
    September 25, 2020
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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