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

    Invictus® Bone Cement, Invictus Spinal Fixation System

    K Number: K221926 · Decision Dec 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    18
    Applicant Total
    93
    Review Days
    172

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    Basic Information

    Device Name
    Invictus® Bone Cement, Invictus Spinal Fixation System
    K Number
    K221926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine, Inc.
    Date Received
    July 1, 2022
    Decision Date
    December 20, 2022
    Product Code
    PML
    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
    PML Bone Cement, Posterior Screw Augmentation

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