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

    MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076

    K Number: K091988 · Decision Jul 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
    K Number
    K091988
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertebral Technologies, Inc.
    Date Received
    July 2, 2009
    Decision Date
    July 30, 2009
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Vertebral Technologies, Inc.

    K Number Device Name
    K131540 INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
    K110226 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
    K110045 INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
    K102277 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
    K093675 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
    K080673 INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE