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

    STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM

    K Number: K073109 · Decision Jun 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    10
    Review Days
    215

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    Basic Information

    Device Name
    STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
    K Number
    K073109
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgicraft , Ltd.
    Date Received
    November 2, 2007
    Decision Date
    June 4, 2008
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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