BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Additive Orthopaedics Patient Specific 3d Printed Bone Segments

    Reg #: 3008650117 · FEI: 3008650117 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    PARAGON 28
    Registration Number
    3008650117
    FEI Number
    3008650117
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14445 Grasslands Dr.
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180239

    Owner / Operator

    Firm Name
    Paragon 28
    Operator Number
    10033376
    Address
    14445 Grasslands Dr.
    City
    Englewood
    State
    CO
    Postal Code
    80112
    Country
    US
    Correspondent
    Steven Mounts

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Additive Orthopaedics Patient Specific 3d Printed Bone Segments

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device