BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LO-PRO SCRW TM,SS 3.5X 12-18MMCORT

    Reg #: 1527105 · FEI: 1000069183 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
    Registration Number
    1527105
    FEI Number
    1000069183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7124 Industrial Park Blvd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143614

    Owner / Operator

    Firm Name
    Avalign Technologies
    Operator Number
    10051835
    Address
    8727 Clinton Park Drive
    City
    Fort Wayne
    State
    IN
    Postal Code
    46825
    Country
    US
    Correspondent
    Heidi Funston

    Products

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

    Proprietary Names

    LO-PRO SCRW TM,SS 3.5X 12-18MMCORT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)