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

    CranioXpand

    K Number: K230211 · Decision Nov 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    58
    Review Days
    299

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    Basic Information

    Device Name
    CranioXpand
    K Number
    K230211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS-Martin L.P.
    Date Received
    January 26, 2023
    Decision Date
    November 21, 2023
    Product Code
    PBJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PBJ Cranial Distraction System

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