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510(k) Data Aggregation

    K Number
    K162124
    Device Name
    Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
    Manufacturer
    DePuy Synthes
    Date Cleared
    2017-03-29

    (240 days)

    Product Code
    JDP, HRS, HWC, JDQ
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    JDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
    Device Description
    The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.
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    K Number
    K110354
    Device Name
    4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
    Manufacturer
    SYNTHES USA
    Date Cleared
    2011-03-04

    (25 days)

    Product Code
    JDP, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    JDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing mutifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
    Device Description
    The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically contoured, stainless steel and titanium plates featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur.
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