BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CranioFit

    Reg #: 2029447 · FEI: 1000518793 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOPLATE, INC.
    Registration Number
    2029447
    FEI Number
    1000518793
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    570 S. Melrose St.
    City
    Placentia
    State
    CA
    ZIP
    92870
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214109

    Owner / Operator

    Firm Name
    Bioplate, Inc.
    Operator Number
    9016123
    Address
    570 S. Melrose St.
    City
    Placentia
    State
    CA
    Postal Code
    92870
    Country
    US
    Correspondent
    Yoon Choi

    Products

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

    Proprietary Names

    CranioFit

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198