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

    POSTERIOR CABLE SCREW

    K Number: K022908 · Decision Jan 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    50
    Review Days
    506

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    Basic Information

    Device Name
    POSTERIOR CABLE SCREW
    K Number
    K022908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology
    Date Received
    September 3, 2002
    Decision Date
    January 22, 2004
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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