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510(k) Data Aggregation

    K Number
    K113399
    Device Name
    IFS SUBTALAR IMPLANT
    Manufacturer
    INTERNAL FIXATION SYSTEMS, INC.
    Date Cleared
    2011-12-20

    (33 days)

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

    INTERNAL FIXATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
    Device Description
    The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
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    K Number
    K110086
    Device Name
    IFS PROFILE PLATES, SCREWS, AND WASHERS
    Manufacturer
    INTERNAL FIXATION SYSTEMS, INC.
    Date Cleared
    2011-09-09

    (240 days)

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

    INTERNAL FIXATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.
    Device Description
    IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.
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    K Number
    K071035
    Device Name
    IFS BONE FIXATION DEVICES
    Manufacturer
    INTERNAL FIXATION SYSTEMS, INC.
    Date Cleared
    2007-08-13

    (123 days)

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

    INTERNAL FIXATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. ***Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.***
    Device Description
    The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screws ranging from 6 to 160mm in length and 1.5mm to 7.3mm in diameter. Threaded, spaded or blunt guide wires range from 0.028 to 0.188 of an inch in diameter and 4 to 12 inches in length. All IFS Bone Fixation Devices are manufactured using 316L stainless steel.
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    K Number
    K061620
    Device Name
    IFS CANNULATED BONE SCREW
    Manufacturer
    INTERNAL FIXATION SYSTEMS, INC.
    Date Cleared
    2006-07-26

    (47 days)

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

    INTERNAL FIXATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
    Device Description
    The IFS Cannulated Screw is a self-tapping, self-drilling screw with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.
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