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510(k) Data Aggregation

    K Number
    K082260
    Device Name
    INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
    Manufacturer
    CALVARY SPINE LLC
    Date Cleared
    2008-10-17

    (70 days)

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

    CALVARY SPINE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra Cervical Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autograft bone. Integra Cervical implant is 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 Petra PLF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The Integra Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. To prevent migration, the Integra Cervical Cage has teeth on its superior and inferior surfaces. A large window allows bony growth to form. It has two tantalum x-ray markers. The Petra PLF Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique. The Petra PLIF 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 PLIF approach. The design is a wedged configuration for ease of insertion. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
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