BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    I.T.S. GMBH

    Reg #: 3004369035 · FEI: 3004369035 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    52
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    I.T.S. GMBH
    Registration Number
    3004369035
    FEI Number
    3004369035
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AUTAL 28
    City
    LASSNITZHOEHE Steiermark
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K051642

    Owner / Operator

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

    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
    Screw, Fixation, Bone, Non-Spinal, Metallic NDJ
    Plate, Fixation, Bone, Non-Spinal, Metallic NDF
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Rod, Fixation, Intramedullary And Accessories HSB
    Nail, Fixation, Bone JDS
    Component, Traction, Non-Invasive KQZ
    Washer, Bolt Nut HTN
    Pin, Fixation, Threaded JDW
    Bit, Drill HTW
    Instrument, Compression HWN
    Instrument, Bending Or Contouring HXP

    Proprietary Names

    CAL - CALCANEUS locking PLATE FR.O.H. Calcaneus Repair System HLS - ITS Hand Locking Plates System CFN - Cannulated Femur Nail System CTN - Cannulated Tibia Nail System CHN - Cannulated Humeral Nail System PHL - PROXIMAL HUMERAL locking PLATE Small & Standard I.T.S. - LRS Locking Reconstruction System PTL - Proximal Medial/Lateral Tibia Locking Plate DFL - Distal Femur Locking Plate CALCANEUS DISTRACTOR PFL - PROlock FIBULA locking PLATE Quadrilaterale Plate Quatrolateral Column Plate Symphysis Plate Curved Posterior Wall Plate Extended J-Plate Posterior Wall Plates I & II Straight Plate Symphysis Plate Sacroiliac Joint Plates PRS/RX - Pelvis Reconstruction System R88 Curved Plate DHL - DISTAL HUMERAL locking PLATE System Dorsolateral Plate Medial Plate FLS - Foot Locking Plate System Twist-Off Screws System HOL - Hallux Osteotomy Locking Plate System HCS - Headless Compression Screw System DRILL BIT CLS - ANTERIOR CLAVICLE locking PLATE - MEDIAL CLS - ANTERIOR CLAVICLE locking PLATE - LATERAL CLS - CLAVICLE locking PLATE CLS - LATERAL CLAVICLE locking PLATE CLS - CLAVICLE locking PLATE 3.5mm PRL - PROlock Radius Locking Plate PROlock Distal Radius Plate DUL - Distal Ulna Locking Plate UOL - Ulna Osteotomy Locking Plate OL - OLECRANON locking PLATE Olecranon Hook Locking Plate Anterolateral Tibiaplate PL - PILON locking PLATE Small & Standard SCL - 3.5 Straight Compression Locking Plate System 2.7, 3.5, 4, 6.5, 7.3 Cannulated Screw & Washer Systems SL - 1.5, 2, 3.5, 4.5 Universal Straight Locking Plate Systems CONNEXX Locking Tibia Nail Epiphysis Screw HEEL PRESS BENDER WIRE

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198