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

    INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)

    K Number: K081194 · Decision May 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    31

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    Basic Information

    Device Name
    INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
    K Number
    K081194
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rsb Spine, LLC
    Date Received
    April 28, 2008
    Decision Date
    May 29, 2008
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Rsb Spine, LLC

    K Number Device Name
    K092540 C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
    K092070 INTERPLATE C
    K071922 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
    K071372 MODIFICATION TO: INTERPLATE VBR SYSTEM
    K070316 INTERPLATE VBR SYSTEM
    K061401 INTERPLATE VBR SYSTEM