BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Cut Screw - Percutaneous Compression Screw

    K Number: K230397 · Decision Jun 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    13
    Review Days
    118

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    Basic Information

    Device Name
    Cut Screw - Percutaneous Compression Screw
    K Number
    K230397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GM Dos Reis Industria e Comercio Ltda.
    Date Received
    February 14, 2023
    Decision Date
    June 12, 2023
    Product Code
    HWC
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HWC Screw, Fixation, Bone

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