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

    XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY

    K Number: K070082 · Decision Apr 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
    K Number
    K070082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertebration,Inc
    Date Received
    January 9, 2007
    Decision Date
    April 20, 2007
    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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    Other Clearances by Vertebration,Inc

    K Number Device Name
    K082466 XYCOR SPINAL IMPLANT