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510(k) Data Aggregation

    K Number
    K213982
    Device Name
    Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
    Manufacturer
    Pacific Instruments
    Date Cleared
    2022-02-17

    (59 days)

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

    Pacific Instruments

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of instruments and implants into the skeletal system.
    Device Description
    Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are metal K-Wires and Pins in a variety of lengths, diameters, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile and are intended to be sterilized at the point of use. All devices are manufactured from medical grade Stainless Steel.
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