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510(k) Data Aggregation

    K Number
    K102449
    Device Name
    BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
    Manufacturer
    BRIGHT SPINE, INC
    Date Cleared
    2011-02-11

    (168 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRIGHT SPINE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
    Device Description
    The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
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