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

    KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

    K Number: K152604 · Decision Jan 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    117

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    Basic Information

    Device Name
    KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
    K Number
    K152604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Incorporated
    Date Received
    September 11, 2015
    Decision Date
    January 6, 2016
    Product Code
    PML
    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
    PML Bone Cement, Posterior Screw Augmentation

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    Other Clearances by Medtronic Sofamor Danek USA, Incorporated

    K Number Device Name
    K150200 CD HORIZON Growth Rod Conversion Set