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510(k) Data Aggregation

    K Number
    K230053
    Device Name
    SimpliFix Hip System
    Manufacturer
    Stabiliz Orthopaedics Inc.
    Date Cleared
    2023-04-19

    (103 days)

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

    Stabiliz Orthopaedics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SimpliFix Hip System is intended for fracture fixation of large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.
    Device Description
    The SimpliFix Hip System is designed for angular and rotational stability when used for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to DHS in basilar neck fractures. The system is comprised of Cannulated and Cross Screws that are used together to aid fracture fixation.
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