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510(k) Data Aggregation
K Number
K230256Device Name
Rebellion, Phantom Multi-Bite Kerrison Rongeur
Manufacturer
Morpheus AG
Date Cleared
2023-03-03
(31 days)
Product Code
HAE
Regulation Number
882.4840Why 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
K221818Device Name
Rebellion; Phantom Multi-Bite Kerrison Rongeur
Manufacturer
Morpheus AG
Date Cleared
2022-10-07
(106 days)
Product Code
HAE
Regulation Number
882.4840Why 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
K200768Device Name
Rebellion, Phantom Multi-Bite Kerrison Rongeur
Manufacturer
Morpheus AG
Date Cleared
2021-05-04
(405 days)
Product Code
HAE
Regulation Number
882.4840Why 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.
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