BEUDAMED
    FDA 510(k) FDA class 3 Unknown 🇺🇸 United States

    SPINAL SPHERE SYSTEM

    K Number: K073274 · Decision Mar 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    36
    Review Days
    117

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    Basic Information

    Device Name
    SPINAL SPHERE SYSTEM
    K Number
    K073274
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Life Spine
    Date Received
    November 21, 2007
    Decision Date
    March 17, 2008
    Product Code
    NVR
    Advisory Committee
    Unknown
    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
    NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

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    K131077 LIFE SPINE PLATEAU SPACER SYSTEM
    K123373 NAUTILUS SPINAL SYSTEM
    K120998 SOLSTICE CROSS CONNECTOR
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