BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XIPHOS ZFUZE

    Reg #: 3009336374 · FEI: 3009336374 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    DiFusion Technologies
    Registration Number
    3009336374
    FEI Number
    3009336374
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1624 HEADWAY CIRCLE
    City
    Austin
    State
    TX
    ZIP
    78754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190544

    Owner / Operator

    Firm Name
    DiFusion Inc.
    Operator Number
    10038060
    Address
    1624 headway circle
    City
    Austin
    State
    TX
    Postal Code
    78754
    Country
    US
    Correspondent
    Sriram Sankar

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ

    Proprietary Names

    XIPHOS ZFUZE

    Establishment Types

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