BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    HOL - Hallux Osteotomy Locking Plate System

    Reg #: 3004369035 · FEI: 3004369035 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    I.T.S. GMBH
    Registration Number
    3004369035
    FEI Number
    3004369035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AUTAL 28
    City
    LASSNITZHOEHE Steiermark
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K131722

    Owner / Operator

    Firm Name
    I.T.S. GmbH
    Operator Number
    9059922
    Address
    Autal 28
    City
    Lassnitzhoehe
    State
    Steiermark
    Postal Code
    8301
    Country
    AT
    Correspondent
    Florian - Grill

    US Agent

    Business Name
    Qserve Group US, Inc.
    Contact Name
    Mindy McCann
    Address
    350 S. Main Street Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    HOL - Hallux Osteotomy Locking Plate System FLS - Foot Locking Plate System HCS - Headless Compression Screw System Twist-Off Screws System

    Establishment Types

    Manufacture Medical Device