BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM

    K Number: K990712 · Decision Jul 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    288
    Review Days
    138

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    Basic Information

    Device Name
    OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
    K Number
    K990712
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    March 4, 1999
    Decision Date
    July 20, 1999
    Product Code
    MJT
    Advisory Committee
    Unknown
    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
    MJT Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

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    FDA Class 3 ·Unknown
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    K122853 NOVEL FIT AND FILL STEM
    K121315 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
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