BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDNEXT SURGICAL BUR

    K Number: K970023 · Decision Feb 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    MEDNEXT SURGICAL BUR
    K Number
    K970023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mednext, Inc.
    Date Received
    January 3, 1997
    Decision Date
    February 28, 1997
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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    Other Clearances by Mednext, Inc.

    K Number Device Name
    K983092 TRITON HUDSON CHUCK ATTACHMENT
    K972308 MEDNEXT 1000 DRILL
    K943108 MEDNEXT MICRO-DRILL
    K935861 MEDNEXT BUR
    K935584 MEDNEXT BUR
    K926547 MEDNEXT 1000 BONE DISSECTING SYSTEM