BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Customized Skull Implant (CSI)

    Reg #: 3009424796 · FEI: 3009424796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KELYNIAM GLOBAL INC.
    Registration Number
    3009424796
    FEI Number
    3009424796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    97 RIVER RD STE A
    City
    COLLINSVILLE
    State
    CT
    ZIP
    06019
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103582

    Owner / Operator

    Firm Name
    Kelyniam Global Inc.
    Operator Number
    10054881
    Address
    97 River Rd, Ste 1
    City
    Canton
    State
    CT
    Postal Code
    06019
    Country
    US
    Correspondent
    Desiree Webb

    Products

    Device Name Product Code
    Plate, Cranioplasty, Preformed, Non-Alterable GXN

    Proprietary Names

    Customized Skull Implant (CSI)

    Establishment Types

    Manufacture Medical Device