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510(k) Data Aggregation

    K Number
    K230817
    Device Name
    TORPEDO Implant System®
    Manufacturer
    Date Cleared
    2024-01-19

    (301 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Deltacor GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TORPEDO Implant System® is intended for sacroiliac fusion for the following indications: · Sacroiliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
    Device Description
    The Deltacor TORPEDO Implant System® consists of canulated spiral-shaped titanium implants (CP Ti Grade 4, ASTM F67) and a placement. The structured surface and special shape of the implant is intended to prevent rotation or displacement of the sacroiliac joint (SI). The cannulated implant can be augmented into the bone in a controlled manner using the laterally inserted holes between the helix. The placement instrument uses a guide wire to achieve precise placement. The TORPEDO Implant System® offers a minimally invasive option for treating SI joint dysfunction.
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