BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DePuy Synthes Trialtis Drill Sleeve

    Reg #: 3026776 · FEI: 1000135253 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)
    Registration Number
    3026776
    FEI Number
    1000135253
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15045 NE MASON ST.
    City
    Parkrose
    State
    OR
    ZIP
    97230
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233255

    Owner / Operator

    Firm Name
    Avalign Instruments & Implants
    Operator Number
    9008280
    Address
    8727 Clinton Park Drive, --
    City
    Fort Wayne
    State
    IN
    Postal Code
    46825
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    DePuy Synthes Trialtis Drill Sleeve

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)