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510(k) Data Aggregation

    K Number
    K192473
    Device Name
    Exsomed Wrist Plating System
    Manufacturer
    Exsomed Corporation
    Date Cleared
    2019-12-03

    (84 days)

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

    Exsomed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.
    Device Description
    The Exsomed Wrist Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of straight tubular plates of varying lengths as well as a 4-hole carpal fusion plate. Screws are provided for plate fixation in locking and non-locking versions and in Ø2.5 and Ø3.2mm diameters. All of the Implants are made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.
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    K Number
    K183603
    Device Name
    INnate Cannulated Screw System
    Manufacturer
    Exsomed Corporation
    Date Cleared
    2019-03-12

    (76 days)

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

    Exsomed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile. The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.
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