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

    INTERLOK BIO-MODULAR HUMERAL STEMS

    K Number: K032507 · Decision Sep 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    441
    Review Days
    22

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    Basic Information

    Device Name
    INTERLOK BIO-MODULAR HUMERAL STEMS
    K Number
    K032507
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    August 14, 2003
    Decision Date
    September 5, 2003
    Product Code
    KWT
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

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