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510(k) Data Aggregation

    K Number
    K121453
    Device Name
    A-GRIX TE RESORABLE BONE VOID FILLER
    Manufacturer
    AG DIGITAL TECHNOLOGY CORP.
    Date Cleared
    2013-02-05

    (265 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AG DIGITAL TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A- GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.
    Device Description
    The A-GRIX TE Resorbable Bone Void Filler consists of 1 bottle of pre-measured surgical grade calcium salt mixture and 1 bottle of mixing solution. When mixed according to the direction, A-GRIX TE forms the biodegradable, biocompatible and radiopaque paste or putty for digitally applying directly or by dispensing into the defect site. Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. This product is supplied sterile for single patient use.
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    K Number
    K101641
    Device Name
    AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
    Manufacturer
    AG DIGITAL TECHNOLOGY CORP.
    Date Cleared
    2011-06-16

    (371 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    AG DIGITAL TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    The AG Thermographic Camera (Model no.: ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image.
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    K Number
    K091688
    Device Name
    A-GRIX RESORBABLE BONE VOID FILLER
    Manufacturer
    AG DIGITAL TECHNOLOGY CORP.
    Date Cleared
    2010-03-02

    (265 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AG DIGITAL TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
    Device Description
    The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules. Because of the special treated granules, the dissolving of A-GRIX Resorbable Bone Void Filler would be longer than other products and closer to the new bone formation. Besides, the different granule size could make it be easy to be filled into the bony defect. When mixed according to the directions, A-GRIX forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. A-GRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
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    K Number
    K083279
    Device Name
    CALTRIX RESORBABLE BONE VOID FILLER
    Manufacturer
    AG DIGITAL TECHNOLOGY CORP.
    Date Cleared
    2009-01-28

    (82 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AG DIGITAL TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CALTRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.
    Device Description
    The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.
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