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

    PEEK SPINAL SPHERES

    K Number: K073105 · Decision Jan 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    PEEK SPINAL SPHERES
    K Number
    K073105
    Device Class
    FDA class 3
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Interbody Innovations, Llp
    Date Received
    November 2, 2007
    Decision Date
    January 3, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NVR), ordered by most recent decision date.

    SPINAL SPHERE SYSTEM

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    SPINAL STABILIZING SPHERE SYSTEM

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    FDA Class 3 ·Unknown

    MODIFICATION TO: SATELLITE SPINAL SYSTEM

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    FDA Class 3 ·Unknown

    SATELLITE SPINAL SYSTEM

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    View all

    Other Clearances by Interbody Innovations, Llp

    K Number Device Name
    K081614 ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
    K062992 SPINAL SPHERES
    K051371 INTERBODY INNOVATIONS CEMENT RESTRICTOR