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

    NEW C-D SYSTEM FOR SPINAL SURGERY

    K Number: K873977 · Decision Dec 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    NEW C-D SYSTEM FOR SPINAL SURGERY
    K Number
    K873977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Co.
    Date Received
    September 29, 1987
    Decision Date
    December 7, 1987
    Product Code
    JDN
    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
    JDN Implant, Fixation Device, Spinal

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