BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    BonOs® Inject Bone Cement; NEO Pedicle Screw System™

    K Number: K222256 · Decision Aug 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    BonOs® Inject Bone Cement; NEO Pedicle Screw System™
    K Number
    K222256
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neo Medical SA
    Date Received
    July 27, 2022
    Decision Date
    August 26, 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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    Other Clearances by Neo Medical SA

    K Number Device Name
    K243693 NEO Pedicle Screw System™
    K212489 BonOs Inject Bone Cement; NEO Pedicle Screw System
    K191796 Neo Cage System
    K181048 Neo Cage System TM
    K171582 NEO Pedicle Screw System™