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

    MODIFICATION TO OSTEONICS SPINAL SYSTEM

    K Number: K010845 · Decision Apr 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    288
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO OSTEONICS SPINAL SYSTEM
    K Number
    K010845
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    March 21, 2001
    Decision Date
    April 18, 2001
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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