BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY

    K Number: K102544 · Decision Jan 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    10
    Review Days
    124

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    Basic Information

    Device Name
    SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
    K Number
    K102544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Inc., Endoscopy Div.
    Date Received
    September 3, 2010
    Decision Date
    January 5, 2011
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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