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

    Ogmend® Implant Enhancement System

    K Number: K223075 · Decision Feb 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    150

    Basic Information

    Device Name
    Ogmend® Implant Enhancement System
    K Number
    K223075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3043
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Woven Orthopedic Technologies
    Date Received
    September 30, 2022
    Decision Date
    February 27, 2023
    Product Code
    QVI
    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
    QVI Screw Sleeve Bone Fixation Device, Spine

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVI), ordered by most recent decision date.

    OGmend® Implant Enhancement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
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    Other Clearances by Woven Orthopedic Technologies

    K Number Device Name
    K233223 OGmend® Implant Enhancement System