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

    Simplify Disc

    K Number: K211757 · Decision Aug 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    91
    Review Days
    74

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    Basic Information

    Device Name
    Simplify Disc
    K Number
    K211757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4515
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuvasive, Inc.
    Date Received
    June 7, 2021
    Decision Date
    August 20, 2021
    Product Code
    QLQ
    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
    QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices

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