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

    NOVEL SPINAL SPACER SYSTEM

    K Number: K080699 · Decision May 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    93
    Review Days
    70

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    Basic Information

    Device Name
    NOVEL SPINAL SPACER SYSTEM
    K Number
    K080699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine, Inc.
    Date Received
    March 12, 2008
    Decision Date
    May 21, 2008
    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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