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

    SPINAL STABILIZING SPHERE SYSTEM

    K Number: K063139 · Decision Apr 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    170

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    Basic Information

    Device Name
    SPINAL STABILIZING SPHERE SYSTEM
    K Number
    K063139
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Biomet Spine
    Date Received
    October 16, 2006
    Decision Date
    April 4, 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

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    Other Clearances by Biomet Spine

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    K141791 BIOMET FUSION SYSTEM
    K121130 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
    K112014 ZYSTON STRAIGHT SPACER SYSTEM
    K103393 POLARIS SPINAL SYSTEM
    K093629 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
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