BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Customized Skull Implant (CSI) with an Integrated Fixation Systems (IFS)

    Reg #: 3009424796 · FEI: 3009424796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    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
    K182711

    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, Alterable GWO

    Proprietary Names

    Customized Skull Implant (CSI) with an Integrated Fixation Systems (IFS) Customized Craniofacial Implant (CCI) with and Integrated Fixation System (IFS)

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198