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510(k) Data Aggregation

    K Number
    K182991
    Device Name
    EPIC Extremity Fusion Plate System
    Manufacturer
    EPIC Extremity, LLC
    Date Cleared
    2019-02-13

    (107 days)

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

    EPIC Extremity, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPIC Extremity Fusion Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.
    Device Description
    The EPIC Extremity Fusion Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.5mm/5.5mm locking and non-locking screws that mate into the plates, 5.5mm fully and partial threaded cancellous, 5.5mm cannulated partial threaded cancellous bone screws as well as various instruments to assist in implanting the system. The EPIC Extremity Fusion Plate System is also designed to be used with various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
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    K Number
    K172441
    Device Name
    EPIC Extremity Fracture Plate System
    Manufacturer
    EPIC Extremity, LLC
    Date Cleared
    2017-11-06

    (87 days)

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

    EPIC Extremity, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
    Device Description
    The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system. The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
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    K Number
    K163038
    Device Name
    EPIC Extremity Snap-Off Screw
    Manufacturer
    EPIC EXTREMITY, LLC
    Date Cleared
    2017-02-28

    (120 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIC EXTREMITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction. Examples include: *Fixation of small bone fragments * Weil osteotomy *Mono-cortical fixation *Osteotomies and fracture fixation in the foot and hand The Snap-Off Screw is intended for single use only.
    Device Description
    The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.
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    K Number
    K153340
    Device Name
    Epic Extremity Plate System
    Manufacturer
    Epic Extremity, LLC
    Date Cleared
    2016-02-09

    (82 days)

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

    Epic Extremity, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epic Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone of the hand, fingers and toes. The system may be used in both adult and pediatric patients. The plates/screws are intended for single use only.
    Device Description
    The Epic Extremity Plate System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and nonlocking screws which mate into the plates, as well as various instruments to assist in implanting the system.
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    K Number
    K153333
    Device Name
    Epic Extremity Cannulated Screw System
    Manufacturer
    Epic Extremity, LLC
    Date Cleared
    2016-01-19

    (61 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epic Extremity, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
    Device Description
    The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.
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