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510(k) Data Aggregation

    K Number
    K151553
    Device Name
    Anterior Cervical Plate System
    Manufacturer
    Osteomed Implantes, LTDA
    Date Cleared
    2016-02-10

    (246 days)

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

    Osteomed Implantes, LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors. deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis. failed previous fusion, spinal stenosis
    Device Description
    The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).
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    K Number
    K143572
    Device Name
    Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
    Manufacturer
    Osteomed Implantes, LTDA
    Date Cleared
    2015-06-10

    (175 days)

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

    Osteomed Implantes, LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage. The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery.
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    K Number
    K150294
    Device Name
    DPZ Pedicular Fixation System
    Manufacturer
    Osteomed Implantes, LTDA
    Date Cleared
    2015-06-05

    (119 days)

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

    Osteomed Implantes, LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DPZ Pedicular Fixation System is intended to provide immobilization 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 thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
    Device Description
    The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.
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