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

    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

    K Number: K122637 · Decision Nov 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    74
    Review Days
    64

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    Basic Information

    Device Name
    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
    K Number
    K122637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Spine
    Date Received
    August 29, 2012
    Decision Date
    November 1, 2012
    Product Code
    FST
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FST Light, Surgical, Fiberoptic

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