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510(k) Data Aggregation

    K Number
    K120538
    Device Name
    PALLS M SPINAL SYSTEM
    Manufacturer
    KOREA BONE BANK CO., LTD
    Date Cleared
    2012-03-23

    (30 days)

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

    KOREA BONE BANK CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pallas M Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).
    Device Description
    The Pallas M Spinal System consists of rods, screws, revision rod system, lilac rod system, MIS pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".
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    K Number
    K102574
    Device Name
    PALLA M SPINAL SYSTEM
    Manufacturer
    KOREA BONE BANK CO., LTD
    Date Cleared
    2011-03-07

    (180 days)

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

    KOREA BONE BANK CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
    Device Description
    The Pallas M Spinal System consists of rods, screws, revision rod system, Miss pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".
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    K Number
    K082509
    Device Name
    EOS SPINAL SYSTEM
    Manufacturer
    KOREA BONE BANK CO., LTD
    Date Cleared
    2008-12-15

    (108 days)

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

    KOREA BONE BANK CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EOS Spinal System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the EOS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
    Device Description
    The EOS Spinal System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism. The EOS Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EOS Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EOS Spinal System.
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