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510(k) Data Aggregation

    K Number
    K222505
    Device Name
    CurvaFix IM System
    Manufacturer
    Date Cleared
    2022-10-27

    (70 days)

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

    CurvaFix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CurvaFix® IM System is intended for fixation of fractures of the pelvis.
    Device Description
    The CurvaFix IM System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the IM Implant from a flexible to rigid state after implantation. The IM Implant can be returned to a flexible state should device explant be required. The implants are available in two diameters (7.5mm and 9.5mm) and lengths ranging from 90mm to 180mm to accommodate a variety of anatomic requirements.
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    K Number
    K180050
    Device Name
    CurvaFix Intramedullary Rodscrew System
    Manufacturer
    Date Cleared
    2019-03-01

    (417 days)

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

    CurvaFix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.
    Device Description
    The CurvaFix Intramedullary Rodscrew System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the Rodscrew from a flexible to rigid state after implantation. The Rodscrew can be returned to a flexible state should explantation be required. The implants are available in a single diameter and an assortment of lengths to accommodate a variety of anatomic requirements.
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