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510(k) Data Aggregation

    K Number
    K213005
    Device Name
    Apollo Ankle Fracture Plating System
    Manufacturer
    GLW Medical Inc
    Date Cleared
    2022-03-11

    (172 days)

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

    GLW Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: - · Lateral Malleolar Fractures - Syndesmosis Injuries - · Medial Malleolar Fractures - Bi-Malleolar Fractures - Tri-Malleolar Fractures - Posterior Malleolar Fractures - Distal Anterior Tibia Fractures - · Vertical Shear Fractures of the Medial Malleolus - Pilon Fractures - Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures - Distal Tibia Periarticular Fractures - Medial Malleolar Avulsion Fractures - · Lateral Malleolar Avulsion Fractures Apollo Locking Screws are intended for use with Apollo's Plating Systems. Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of bone fragments. Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
    Device Description
    ApolloTM Ankle Fracture Plating System consists of implantable components that will be include an array of Titanium alloy Ti-6AL-4V ELI (ASTM F3001) / PEEK plates and locking and non-locking screws. The screws are offered in configurations that include a range of Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the implants. The implantable devices are provided sterile via Gamma irradiation.
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    K Number
    K200291
    Device Name
    CREED™ Cannulated Screws
    Manufacturer
    GLW Medical Inc
    Date Cleared
    2020-12-16

    (315 days)

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

    GLW Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, non-unions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.
    Device Description
    CREEDTM Cannulated Screws consists of subject components that will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed or headless compression. All screws are self-drilling and self-tapping. The screws are offered in configurations that include a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA-600 PEEK (ASTM F2026). A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.
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