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510(k) Data Aggregation

    K Number
    K081614
    Device Name
    ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
    Manufacturer
    INTERBODY INNOVATIONS, LLP
    Date Cleared
    2008-09-05

    (88 days)

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

    INTERBODY INNOVATIONS, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom. The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form. The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach. The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
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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?
    Applicant Name (Manufacturer) :

    INTERBODY INNOVATIONS, LLP

    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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