BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A 200 PS Knee System

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

    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
    K190122

    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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    A 200 PS Knee System

    Establishment Types

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