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Found 25 results
510(k) Data Aggregation
K Number
K242759Device Name
Geister K-Rex rongeurs
Manufacturer
Geister Medizin Technik GmbH
Date Cleared
2025-06-06
(267 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
K223596Device Name
SQ.line KERRISON
Manufacturer
Aesculap Inc.
Date Cleared
2023-06-29
(209 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
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?
Product Code :
HAE
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?
Product Code :
HAE
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
K210741Device Name
KLS Martin Neuro Rongeurs
Manufacturer
KLS-MARTIN L.P.
Date Cleared
2022-06-03
(448 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
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?
Product Code :
HAE
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
K200383Device Name
Wiggins Medical Surgical Instruments
Manufacturer
Wiggins Medical
Date Cleared
2020-07-21
(154 days)
Product Code
HAE, HTX
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
K200387Device Name
Ace Medical Surgical Instruments
Manufacturer
Ace Medical
Date Cleared
2020-07-21
(154 days)
Product Code
HAE, HTX
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
K180949Device Name
Steribite
Manufacturer
RJR Surgical, Inc.
Date Cleared
2018-11-08
(211 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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
K161744Device Name
Symmetry Sharp Kerrison Rongeur
Manufacturer
Symmetry Surgical Inc.
Date Cleared
2016-09-07
(75 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Product Code :
HAE
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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