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510(k) Data Aggregation

    K Number
    K110153
    Device Name
    SFC VERTEBRAL BODY REPLACEMENT
    Manufacturer
    KONIGSEE IMPLANTATE GMBH
    Date Cleared
    2011-10-12

    (266 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONIGSEE IMPLANTATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC.10 is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFCTM may be used with autograft or allograft.
    Device Description
    The SFCTM acts as an expandable spacer to maintain proper vertebral body spacing and angulation following vertebrectomy. The SFCTM VBR is manufactured from Ti6Al4V.
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