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510(k) Data Aggregation

    K Number
    K142661
    Device Name
    Bi-Portal Bone Graft Delivery Device
    Manufacturer
    Spinal Surgical Strategies, LLC
    Date Cleared
    2014-12-11

    (84 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spinal Surgical Strategies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.
    Device Description
    The Bi-Portal Bone Graft Delivery Device is comprised of a 21.0 cm length rectangular syringe barrel for surgical site access and bone graft material delivery; a compatible syringe plunger for pushing the allograft or autograft into the operative site; and, an attachable funnel reservoir for loading prepared material. The barrel has an 8.0 mm by 12.0 mm closed-end tapered distal shaft with a pair of longitudinal bilateral ejection holes near the distal end for material effusion into the surgical space. The barrel can be partially filled with up to 4.0 cc of material and refilled in-situ using the attachable funnel. When used as an ancillary device to orthopedic surgical procedures that require the placement of autograft or allograft, the Bi-Portal Device can deliver a prepared amount of material. There are no luer lock components to the bi-portal design is intended to result in graft material effusion through the two laterally placed sideholes. This allows the material to be selectively placed within the surgical space adjacent to the Device barrel tip.
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