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510(k) Data Aggregation

    K Number
    K250141
    Device Name
    Synthecure Synthetic Calcium Sulfate
    Manufacturer
    Austin Medical Ventures, Inc.
    Date Cleared
    2025-05-16

    (119 days)

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

    **Austin **Medical Ventures, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process. Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
    Device Description
    Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
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    K Number
    K181528
    Device Name
    Austin Miller Large External Fixation System
    Manufacturer
    Austin Miller Trauma LLC
    Date Cleared
    2019-02-28

    (262 days)

    Product Code
    KTT, JDW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Austin **Miller Trauma LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
    Device Description
    The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
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    K Number
    K161587
    Device Name
    Memodyn Staple
    Manufacturer
    AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
    Date Cleared
    2017-02-01

    (238 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    **AUSTIN **& ASSOCIATES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
    Device Description
    Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
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    K Number
    K061422
    Device Name
    SURGICAL DRAPES
    Manufacturer
    AUSTIN MEDICAL, INC.
    Date Cleared
    2006-09-25

    (125 days)

    Product Code
    KKX, KKK
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    **AUSTIN **MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
    Device Description
    Various types of surgical drapes
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