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510(k) Data Aggregation

    K Number
    K040363
    Device Name
    CERAMIC TIPPED SKULL PIN
    Manufacturer
    THE JEROME GROUP, INC.
    Date Cleared
    2004-04-12

    (59 days)

    Product Code
    LYT
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    LYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.
    Device Description
    The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points.
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    K Number
    K983685
    Device Name
    BONE BAND
    Manufacturer
    CHAPEL AND ASSOC.
    Date Cleared
    1998-12-04

    (45 days)

    Product Code
    LYT
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    LYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates. This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.
    Device Description
    The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.
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    K Number
    K980594
    Device Name
    OSTEONICS FX-CABLELOK GRIP COMPONENTS
    Manufacturer
    OSTEONICS CORP.
    Date Cleared
    1998-05-05

    (77 days)

    Product Code
    LYT
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    LYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
    Device Description
    The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.
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