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

    KYPHON EXPRESS II INFLATABLE BONE TAMPS

    K Number: K123771 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    33
    Review Days
    14

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    Basic Information

    Device Name
    KYPHON EXPRESS II INFLATABLE BONE TAMPS
    K Number
    K123771
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic
    Date Received
    December 7, 2012
    Decision Date
    December 21, 2012
    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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