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510(k) Data Aggregation

    K Number
    K242759
    Device Name
    Geister K-Rex rongeurs
    Manufacturer
    Geister Medizin Technik GmbH
    Date Cleared
    2025-06-06

    (267 days)

    Product Code
    HAE
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEISTER® K-Rex™ rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    Geister Geister® K-Rex™ rongeurs are reusable stainless steel instruments that are coated with TiAIN that are sterilizable and packaged non-sterile.
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    K Number
    K223596
    Device Name
    SQ.line KERRISON
    Manufacturer
    Aesculap Inc.
    Date Cleared
    2023-06-29

    (209 days)

    Product Code
    HAE
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.
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    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
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    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
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    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
    K210741
    Device Name
    KLS Martin Neuro Rongeurs
    Manufacturer
    KLS-MARTIN L.P.
    Date Cleared
    2022-06-03

    (448 days)

    Product Code
    HAE
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
    Device Description
    The KLS Martin Neuro Rongeurs are manual, reusable, stainless-steel instruments. They are provided non-sterile and must be cleaned and sterilized by the end user before use. Validated methods are provided in the instructions for use that accompany each device. The instruments are available coated or uncoated in a variety of styles, with options for a range of cutting angles, shaft lengths and profiles, jaw widths, and handle designs. Additionally, the KLS Martin Neuro Rongeurs can have a push button opening mechanism to allow separation of the long shafts allowing for improved cleaning and sterilization.
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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
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    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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    K Number
    K200383
    Device Name
    Wiggins Medical Surgical Instruments
    Manufacturer
    Wiggins Medical
    Date Cleared
    2020-07-21

    (154 days)

    Product Code
    HAE, HTX
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    The Wiggins Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (AITiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including: - Different handles (Large, Standard, for use with Rotating Shafts) - Different shaft lengths (6-14 inches) - Different Bite Sizes (0.5-6 mm) - Different Angles (40° and 90°, up and down) - Different Footplates (Standard, Thin and Ultra-Thin) - With or without ejector - Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
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    K Number
    K200387
    Device Name
    Ace Medical Surgical Instruments
    Manufacturer
    Ace Medical
    Date Cleared
    2020-07-21

    (154 days)

    Product Code
    HAE, HTX
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including: - Different handles (Large, Standard, for use with Rotating Shafts) - Different shaft lengths (6-14 inches) - Different Bite Sizes (0.5-6 mm) - Different Angles (40° and 90°, up and down) - Different Footplates (Standard, Thin and Ultra-Thin) - With or without ejector - Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
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    K Number
    K180949
    Device Name
    Steribite
    Manufacturer
    RJR Surgical, Inc.
    Date Cleared
    2018-11-08

    (211 days)

    Product Code
    HAE
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.
    Device Description
    Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.
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    K Number
    K161744
    Device Name
    Symmetry Sharp Kerrison Rongeur
    Manufacturer
    Symmetry Surgical Inc.
    Date Cleared
    2016-09-07

    (75 days)

    Product Code
    HAE
    Regulation Number
    882.4840
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).
    Device Description
    The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).
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