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

    MODIFICATION TO: INTERPLATE VBR SYSTEM

    K Number: K071372 · Decision Jun 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    7
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO: INTERPLATE VBR SYSTEM
    K Number
    K071372
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rsb Spine, LLC
    Date Received
    May 16, 2007
    Decision Date
    June 11, 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 Rsb Spine, LLC

    K Number Device Name
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    K092070 INTERPLATE C
    K081194 INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
    K071922 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
    K070316 INTERPLATE VBR SYSTEM
    K061401 INTERPLATE VBR SYSTEM