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510(k) Data Aggregation

    K Number
    K211474
    Device Name
    Kleiner KG2 System
    Date Cleared
    2021-09-14

    (125 days)

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

    Baat Medical Products BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
    Device Description
    The Kleiner KG2 is a cage intended for lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole. The cage is additively manufactured from titanium alloy. The KG2 cage may be used with coverplate. The sterile Kleiner KG2 implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments are included for disc preparation, trial sizing, and repositioning/removal.
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    K Number
    K201830
    Device Name
    ANSER Clavicle Pin
    Date Cleared
    2020-08-27

    (56 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Baat Medical Products BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ANSER Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
    Device Description
    The ANSER Clavicle Pin is a device intended to be used for intramedullary fixation of mid-shaft clavicle fractures. The device consists of three parts. The main component is a nail, that is placed within the medullary canal of the fractured clavicle. It has a threaded medial end for fixation into the bone. At the lateral end an endcap is placed after insertion for lateral fixation of the pin. In this way the pin is secured both medially and laterally.
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