BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Renovis A400 Hip Joint Replacement Prosthesis

    Reg #: 3015398319 · FEI: 3007932279 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Kyocera Medical Technologies, Inc.
    Registration Number
    3015398319
    FEI Number
    3007932279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1289 Bryn Mawr Ave Ste A
    City
    Redlands
    State
    CA
    ZIP
    92374
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112897

    Owner / Operator

    Firm Name
    Kyocera Medical Technologies, Inc.
    Operator Number
    10030880
    Address
    1289 Bryn Mawr Avenue, Suite A
    City
    Redlands
    State
    CA
    Postal Code
    92374
    Country
    US
    Correspondent
    Anthony DeBenedictis

    Products

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

    Proprietary Names

    Renovis A400 Hip Joint Replacement Prosthesis

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198