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    K Number
    K142655
    Device Name
    CB PROT II Posterior Spinal System
    Manufacturer
    CHIN BONE TECHNIQUE CORP
    Date Cleared
    2015-01-26

    (130 days)

    Product Code
    MNHMNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHIN BONE TECHNIQUE CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications: - Trauma (i.e. fracture or dislocation). - Spinal stenosis. - Vertebral tumors. - Pseudoarthrosis and failed previous fusion in skeletally mature patients. - Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra. The system is intended to be used with autograft or allograft to facilitate fusion.
    Device Description
    The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
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