BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Montage Settable Bone Putty

    Reg #: 3005972619 · FEI: 3005972619 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ABYRX, INC.
    Registration Number
    3005972619
    FEI Number
    3005972619
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 Fairfield Avenue, Suite 1
    City
    Stamford
    State
    CT
    ZIP
    06902
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242050

    Owner / Operator

    Firm Name
    ORTHOCON, INC.
    Operator Number
    9064695
    Address
    700 Fairfield Ave, Suite 1
    City
    Stamford
    State
    CT
    Postal Code
    06902
    Country
    US

    Products

    Device Name Product Code
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
    Wax, Bone MTJ
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Montage Settable Bone Putty

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device