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

    GUARDIAN INFLATABLE BONE EXPANDER SYSTEM

    K Number: K111593 · Decision Nov 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    5
    Review Days
    164

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    Basic Information

    Device Name
    GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
    K Number
    K111593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bm Korea Co., Ltd.
    Date Received
    June 7, 2011
    Decision Date
    November 18, 2011
    Product Code
    NDN
    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
    NDN Cement, Bone, Vertebroplasty

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    Other Clearances by Bm Korea Co., Ltd.

    K Number Device Name
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    K120353 SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
    K111820 SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE