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510(k) Data Aggregation

    K Number
    K220892
    Device Name
    ExsoMed INnate NanoTM Lag Screw System
    Manufacturer
    Date Cleared
    2022-04-27

    (30 days)

    Product Code
    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 INnate Nano™ Lag 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, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The purpose of this Special 510(k) is to add additional sizes and geometry to InFrame™ Cannulated Fixation System. The ExsoMed INnate Nano Lag Screw System includes cannulated stainless screws with a diameter of 1.5mm and lengths ranging from 6 mm to 26 mm.
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