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510(k) Data Aggregation

    K Number
    K991862
    Device Name
    MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
    Manufacturer
    MICOMED GMBH
    Date Cleared
    2000-01-13

    (226 days)

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

    MICOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micomed Posterior Doublerod System is a pedicle screw system indicated for treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-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. The Micomed Posterior Doublerod System is a pedicle screw system 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 (pseudoarthrosis). When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scollosis, Scheuermann's disease); degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.
    Device Description
    The Micomed Posterior Doublerod System is a low profile, top-loading spinal fixation system available in titanium. The system consists of pedicle screws of varying lengths and diameters, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System.
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    K Number
    K982006
    Device Name
    MICOMED - HALM ZIELKE INSTRUMENTATION
    Manufacturer
    MICOMED GMBH
    Date Cleared
    1999-01-20

    (226 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.
    Device Description
    The principal components of the MICOMED Halm Zielke Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong. The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired.
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