BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Valeo II Interbody Fusion Device System - Lumbar

    Reg #: 3005032068 · FEI: 3005032068 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SINTX Technologies Inc.
    Registration Number
    3005032068
    FEI Number
    3005032068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1885 W 2100 S
    City
    Salt Lake City
    State
    UT
    ZIP
    84119
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142347

    Owner / Operator

    Firm Name
    SINTX Technologies
    Operator Number
    9071516
    Address
    1885 W 2100 S
    City
    Salt Lake City
    State
    UT
    Postal Code
    84119
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Valeo II Interbody Fusion Device System - Lumbar

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)