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

    EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE

    K Number: K050997 · Decision Oct 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    1
    Review Days
    170

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    Basic Information

    Device Name
    EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
    K Number
    K050997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flexuspine, Inc.
    Date Received
    April 20, 2005
    Decision Date
    October 7, 2005
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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