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510(k) Data Aggregation

    K Number
    K072231
    Device Name
    THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
    Manufacturer
    ESM TECHNOLOGIES, LLC.
    Date Cleared
    2007-12-26

    (138 days)

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

    ESM TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
    Device Description
    The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.
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