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510(k) Data Aggregation

    K Number
    K073274
    Device Name
    SPINAL SPHERE SYSTEM
    Manufacturer
    LIFE SPINE
    Date Cleared
    2008-03-17

    (117 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.
    Device Description
    The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.
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    K Number
    K073105
    Device Name
    PEEK SPINAL SPHERES
    Manufacturer
    INTERBODY INNOVATIONS, LLP
    Date Cleared
    2008-01-03

    (62 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.
    Device Description
    These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm. Materials: PEEK Optima per ASTM F2026 Function: The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.
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    K Number
    K062992
    Device Name
    SPINAL SPHERES
    Manufacturer
    INTERBODY INNOVATIONS LLP
    Date Cleared
    2007-07-27

    (298 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.
    Device Description
    The Spinal Spheres consist of CoCtMo spheres which may be implanted from L3 to S1 to 16 morary stabilization in order to promote fusion. These spheres are available in Ø10-Ø16mm diameters.
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    K Number
    K063139
    Device Name
    SPINAL STABILIZING SPHERE SYSTEM
    Manufacturer
    BIOMET SPINE
    Date Cleared
    2007-04-04

    (170 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Stabilizing Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.
    Device Description
    The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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    K Number
    K060415
    Device Name
    MODIFICATION TO: SATELLITE SPINAL SYSTEM
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Date Cleared
    2007-01-05

    (322 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
    Device Description
    The SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or medical grade PEEK-OPTIMA LT1, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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    K Number
    K051320
    Device Name
    SATELLITE SPINAL SYSTEM
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Date Cleared
    2005-09-09

    (112 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NVR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
    Device Description
    The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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