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

    SPACE CPSXL BONE CEMENT

    K Number: K061531 · Decision Aug 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    106
    Applicant Total
    5
    Review Days
    89

    Basic Information

    Device Name
    SPACE CPSXL BONE CEMENT
    K Number
    K061531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DFINE, INC.
    Date Received
    June 2, 2006
    Decision Date
    August 30, 2006
    Product Code
    NDN
    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
    NDN Cement, Bone, Vertebroplasty

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