BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads

    Reg #: 3006536454 · FEI: 3006536454 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KYOCERA Corporation Shiga Higashiomi Plant Block 2
    Registration Number
    3006536454
    FEI Number
    3006536454
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10-1 KAWAI-CHO
    City
    Higashiomi-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K072656

    Owner / Operator

    Firm Name
    KYOCERA Corporation
    Operator Number
    9097359
    Address
    6 Takeda Tobadono-cho, Fushimi-ku, --
    City
    Kyoto
    State
    JP-NOTA
    Postal Code
    612-8501
    Country
    JP
    Correspondent
    Masato - Atsumi

    US Agent

    Business Name
    Hastings Regulatory Consulting, LLC
    Contact Name
    Cheryl Hastings
    Address
    2256 E Blossom Lane
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    574 5274220

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)