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510(k) Data Aggregation

    K Number
    K230256
    Device Name
    Rebellion, Phantom Multi-Bite Kerrison Rongeur
    Manufacturer
    Morpheus AG
    Date Cleared
    2023-03-03

    (31 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morpheus AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
    Device Description
    The REBELLION is a Bone Punch and it is available in the length 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
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    K Number
    K221818
    Device Name
    Rebellion; Phantom Multi-Bite Kerrison Rongeur
    Manufacturer
    Morpheus AG
    Date Cleared
    2022-10-07

    (106 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morpheus AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
    Device Description
    The Rebellion is a Bone Punch and it is available in the length 160 mm with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer-Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
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    K Number
    K200768
    Device Name
    Rebellion, Phantom Multi-Bite Kerrison Rongeur 
    Manufacturer
    Morpheus AG
    Date Cleared
    2021-05-04

    (405 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morpheus AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
    Device Description
    The Rebellion is a Bone Punch and it is available in two lengths (200 – 250 mm) with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
    Ask a Question

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