BEUDAMED
    FDA Registration Active 🇺🇸 United States

    fusion

    Reg #: 3010049501 · FEI: 3010049501 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    JATEX, INC.
    Registration Number
    3010049501
    FEI Number
    3010049501
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    551 Shawnee Drive
    City
    Nappanee
    State
    IN
    ZIP
    46550
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142498

    Owner / Operator

    Firm Name
    Jatex, Inc.
    Operator Number
    10043044
    Address
    551 Shawnee Drive
    City
    Nappanee
    State
    IN
    Postal Code
    46550
    Country
    US
    Correspondent
    Devon Hochstetler

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    fusion

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)