BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

    K Number: K040939 · Decision May 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    16
    Review Days
    30

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    Basic Information

    Device Name
    SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K Number
    K040939
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    April 12, 2004
    Decision Date
    May 12, 2004
    Product Code
    HRX
    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
    HRX Arthroscope

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