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

    SMART ADJUSTER (SA201)

    K Number: K962239 · Decision Jan 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    213

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    Basic Information

    Device Name
    SMART ADJUSTER (SA201)
    K Number
    K962239
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma
    Date Received
    June 11, 1996
    Decision Date
    January 10, 1997
    Product Code
    LXM
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXM Manipulator, Plunger-Like Joint

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