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510(k) Data Aggregation
K Number
K142294Device Name
FlexiMarc Marker
Manufacturer
CORTEX MANUFACTURING, INC.
Date Cleared
2015-03-26
(220 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CORTEX MANUFACTURING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarcs can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Device Description
FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It will be available in varying lengths from 3 MM to 4 CM overall and will range in diameter from 0.35 MM to 1.6 MM. It will be available in single and multi-node formats. These are detailed in the table below. FlexiMarc is delivered in sterile preexisting needles ranging from 25 GA to 14 GA, solo in a sterile pouch, or in nonsterile bulk.
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K Number
K102506Device Name
MIXED MEDIA MARKER
Manufacturer
CORTEX MANUFACTURING, INC.
Date Cleared
2011-01-12
(133 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CORTEX MANUFACTURING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
Device Description
These implanted markers are used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The markers are fabricated of biocompatible materials. Specifically, gold (99.99%), medical grade titanium or PEEK Optima (polymer) with a medical grade stainless steel core.
They are available in varying lengths and have a diameter of 1.0 MM (+/- 0.2 MM)
They are intended for single use and are permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
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K Number
K100267Device Name
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
Manufacturer
CORTEX MANUFACTURING, INC.
Date Cleared
2010-02-24
(26 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CORTEX MANUFACTURING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Device Description
FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It is available in varying lengths from 2 mm overall to 4 CM overall and ranges in diameter from 0.5 mm to 1.6 mm so that it can be identified in the varying medical imaging formats. FlexiMarc is delivered in sterile preexisting needles ranging from 20 GA to 16 GA.
FlexiMarc is intended for single use and is permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
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