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

    Orthobond Mariner Pedicle Screw System

    K Number: DEN220015 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    767

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    Basic Information

    Device Name
    Orthobond Mariner Pedicle Screw System
    K Number
    DEN220015
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3071
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Orthobond Coporation
    Date Received
    February 28, 2022
    Decision Date
    April 5, 2024
    Product Code
    QZY
    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
    QZY Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating