BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ReBOSSIS QDS

    Reg #: 3011415547 · FEI: 3011415547 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHOREBIRTH CO., LTD.
    Registration Number
    3011415547
    FEI Number
    3011415547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-17-43 Chigasaki-Higashi
    City
    Tsuzukiku, Yokohama Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K240453

    Owner / Operator

    Firm Name
    ORTHOREBIRTH Co., Ltd.
    Operator Number
    10048526
    Address
    3-17-43 Chigaski-Higashi
    City
    Tsuzukiku, Yokohama
    State
    Kanagawa
    Postal Code
    224-0033
    Country
    JP

    US Agent

    Business Name
    PaxMed International LLC
    Contact Name
    Floyd Larson
    Address
    1925 Palomar Oaks Way Ste 210
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    858 7921235

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    ReBOSSIS QDS ReBOSSIS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device