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

    SyntheCel Dura Repair

    K Number: K212943 · Decision Jan 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    45
    Review Days
    135

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    Basic Information

    Device Name
    SyntheCel Dura Repair
    K Number
    K212943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    September 15, 2021
    Decision Date
    January 28, 2022
    Product Code
    GXQ
    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
    GXQ Dura Substitute

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