BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Initia Total Hip System

    Reg #: 3013557690 · FEI: 3013557690 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    YASOJIMA PROCEED CO., LTD. Sendai Factory
    Registration Number
    3013557690
    FEI Number
    3013557690
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-1-4, Kamisakuragi
    City
    Tomiya-shi Miyagi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160895

    Owner / Operator

    Firm Name
    Yasojima proceed co., ltd.
    Operator Number
    10054443
    Address
    3-2-11 Minatojimaminamimachi, Chuou-ku
    City
    Kobe-shi?
    State
    Hyogo
    Postal Code
    6500047
    Country
    JP
    Correspondent
    Takuya Kubo

    US Agent

    Business Name
    Globizz Corporation
    Contact Name
    Takahiro Haruyama
    Address
    970 W. 190th St. Suite 200
    City
    Torrance
    State
    CA
    ZIP
    90502
    Country
    US
    Email
    [email protected]
    Phone
    310 5383860

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Initia Total Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)