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510(k) Data Aggregation

    K Number
    K201430
    Device Name
    InFrame™ Cannulated Fixation System
    Manufacturer
    ExsoMed, Corp.
    Date Cleared
    2020-06-20

    (19 days)

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

    ExsoMed, Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular fractures and non-unions of small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metatarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The purpose of this Special 510(k) is to add additional sizes to INnate™ Cannulated Screw System. The InFrame™ Cannulated Fixation System includes cannulated stainless screws with a diameter of 2.0 mm and lengths ranging from 10 mm to 50 mm.
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