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

    SPINAL SPHERES

    K Number: K062992 · Decision Jul 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    4
    Review Days
    298

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    Basic Information

    Device Name
    SPINAL SPHERES
    K Number
    K062992
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Interbody Innovations, Llp
    Date Received
    October 2, 2006
    Decision Date
    July 27, 2007
    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

    Similar 510(k) Clearances

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    MODIFICATION TO: SATELLITE SPINAL SYSTEM

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    Other Clearances by Interbody Innovations, Llp

    K Number Device Name
    K081614 ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
    K073105 PEEK SPINAL SPHERES
    K051371 INTERBODY INNOVATIONS CEMENT RESTRICTOR