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510(k) Data Aggregation

    K Number
    K130306
    Device Name
    INCITE ANCHORED CERVICAL INTERBODY DEVICE
    Manufacturer
    INCITE INNOVATION LLC
    Date Cleared
    2013-04-11

    (63 days)

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

    INCITE INNOVATION LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
    Device Description
    The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers
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    K Number
    K122008
    Device Name
    INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
    Manufacturer
    INCITE INNOVATION LLC
    Date Cleared
    2012-11-16

    (130 days)

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

    INCITE INNOVATION LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
    Device Description
    The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.
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    K Number
    K093808
    Device Name
    INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE
    Manufacturer
    INCITE INNOVATION LLC
    Date Cleared
    2010-03-24

    (103 days)

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

    INCITE INNOVATION LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
    Device Description
    The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent interbody spacer equipped with internal fixation anteriorly through the use of an integrated anchoring mechanism. The implant is made from materials with a long history of use in this type of application which include PEEK, titanium alloy, and tantalum. The implant has two chambers to accommodate autograft.
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