BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KYOCERA Medical Corporation Shiga Higashiomi Plant

    Reg #: 3006536454 · FEI: 3006536454 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    KYOCERA Medical Corporation Shiga Higashiomi Plant
    Registration Number
    3006536454
    FEI Number
    3006536454
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10-1 KAWAI-CHO
    City
    Higashiomi-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160895

    Owner / Operator

    Firm Name
    KYOCERA Medical Corporation
    Operator Number
    9097359
    Address
    6 Takeda Tobadono-cho, Fushimi-ku, --
    City
    Kyoto
    State
    JP-NOTA
    Postal Code
    612-8450
    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/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA

    Proprietary Names

    KINAMED 26MM BIOCERAM-Z TOTAL HIP FEMORAL BALL DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads CARDO MEDICAL CERAMIC HIP SYSTEM 32mm and 36mm Alumina Ceramic Femoral Heads KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL ATH CERAMIC UHMWPE TOTAL HIP SYSTEM KINAMED 32MM BIOCERAM-Z TOTAL HIP BALL DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads KINAMED 32MM BIOCERAM-Z TOTAL HIP FEMORAL BALL KINAMED CERAMIC ATH TOTAL HIP -28MM BALL KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)