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

    MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

    K Number: K243526 · Decision Dec 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    36
    Review Days
    21

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    Basic Information

    Device Name
    MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
    K Number
    K243526
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthocon, Inc.
    Date Received
    November 14, 2024
    Decision Date
    December 5, 2024
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Orthocon, Inc.

    K Number Device Name
    K261265 Permatage XT Settable Bone Putty
    K261439 Permatage Flowable, Settable Hemostatic Bone Paste
    K253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
    K253732 Permatage Flowable, Settable Bone Paste
    K253854 MONTAGE XT Cranial Cement
    K243506 Montage-XT Settable Bone Putty
    K241027 Permatage Settable Bone Putty
    K233566 Montage-XT Settable, Resorbable Bone Putty
    K242050 Montage Settable Bone Putty
    K232771 Montage Flowable Settable, Resorbable Bone Paste
    Search all 36 clearances from Orthocon, Inc. →