BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ORTHOFIX SRL

    Reg #: 9680825 · FEI: 3002807827 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    102
    Establishment Types
    2
    Classifications
    34

    Registration Details

    Registration Name
    ORTHOFIX SRL
    Registration Number
    9680825
    FEI Number
    3002807827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA DELLE NAZIONI 9
    City
    BUSSOLENGO Verona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K944092

    Owner / Operator

    Firm Name
    ORTHOFIX SRL
    Operator Number
    9011783
    Address
    VIA DELLE NAZIONI 9, --
    City
    BUSSOLENGO
    State
    Verona
    Postal Code
    37012
    Country
    IT
    Correspondent
    ELVIRA - TACCARELLI

    US Agent

    Business Name
    ORTHOFIX LLC
    Contact Name
    Amira Milutinovic
    Address
    3451 Plano Pkwy
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US
    Email
    [email protected]
    Phone
    214 9372196

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Component, Traction, Invasive JEC
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN
    Component, Traction, Non-Invasive KQZ
    Osteotome HWM
    Plate, Fixation, Bone HRS
    Wrench HXC
    Rod, Fixation, Intramedullary And Accessories HSB
    Guide, Surgical, Instrument FZX
    Pin, Fixation, Threaded JDW
    Grid, Radiographic IXJ
    Mallet, Surgical, General & Plastic Surgery GFJ
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Tape, Measuring, Rulers And Calipers FTY
    Orthopedic Manual Surgical Instrument LXH
    Plate, Bone, Growth Control, Pediatric, Epiphysiodesis OBT
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Automated Radiological Image Processing Software QIH
    System, Cement Removal Extraction LZV
    Nail, Fixation, Bone JDS
    Scissors, Orthopedic, Surgical HRR
    System, Image Processing, Radiological LLZ
    Gauge, Depth HTJ
    Screwdriver HXX
    Reamer HTO
    Bit, Drill HTW
    Apparatus, Traction, Non-Powered HST
    Adaptor, Recreational ILT
    System, X-Ray, Film Marking, Radiographic JAC
    Device, Fixation, Proximal Femoral, Implant JDO

    Proprietary Names

    JPS Orthopedic Tray HYBRID FIXATOR SYSTEM SHEFFIELD RING FIXATOR FRAGMENT FIXATION SYSTEM MJ-Flex Orthofix MJ-FLEX THE NEW METAIZEAU NAIL CONTOURS PROXIMAL HUMERAL PLATE (PHP) Galaxy UNYCO System Galaxy UNYCO Orthofix TrueLok Hexapod System (TL-HEX) V2 True Lok System Rival Bite Compression Screws LEG SUPPORT COMPONENT Osteotome SOLE™ Medial Column Fusion Plate G-Beam Fusion Beaming System Allen Wrench Agile Nail Drill guide FITBONE® TAA XCALIBER BONE SCREWS TITANIUM SCREWS XCALIBER EXTERNAL FIXATOR PENNIG DYNAMIC WRIST FIXATOR BONE SCREWS PELVIC FIXATOR SMALL BLUE D.A.F. ADULT LIMB RECONSTRUCTION SYSTEM RADIOLUCENT WRIST FIXATOR PENNIG MINIFIXATOR PROCALLUS FIXATOR ADVANCED LIMB RECONSTRUCTION SYSTEM PERTROCHANTERIC FIXATOR MINIRAIL SYSTEM PREFIX FIXATOR ELBOW FIXATOR DYNAMIC AXIAL FIXATOR PAEDIATRIC LIMB RECONSTRUCTION SYSTEM Rival View Plating System Rival Reduce Fracture Plating System GALAXY FIXATION SYSTEM GALAXY WRIST GRID PLATE MALLET, SURGICAL, GENERAL & PLASTIC SURGERY GALAXY UNYCO GALAXY UNYCO DIAPHYSEAL TIBIA KIT TrueLok Evo Instrument guide Orthofix Chimaera Hip Fracture System - Trochanteric Nailing System Chimaera Hip Fracture System Orthofix Rival Orthopedic Surgical Instruments Orthofix Orthopedic Surgical Instruments GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATE (STAINLESS STEEL) GUIDED GROWTH PLATE SYSTEM TRUE LOK SYSTEM TRUE LOK PLUS SYSTEM OSCAR PRO STERILE KIT FOR PERISTALTIC PUMP US MIOT PLATING SYSTEM OrthoNext Platform System OSCAR 3 HA BONE SCREWS Fitbone TAA OSCAR, MODEL OE3000 OSCAR SCISSORS, ORTHOPEDIC, SURGICAL ORTHONEXT™ PLATFORM SYSTEM ORTHONEXT™ TL-HEX SOFTWARE MODULE Guided Growth Plate System Plus Guided Growth Plate System G-BEAM SIZING GAUGE TrueLok Elevate Screwdriver FLEXIBLE REAMER FLEXIBLE REAMER SYSTEM GUIDED GROWTH SYSTEM Galaxy UNYCO Femur&Knee Bridging Implantable Bone Screws Fitbone Trochanteric Fitbone® Transport And Lengthening System Contours VPS III Volar Plating System (bone plate) Contours VPS Volar Plating System RIVALTM View Plating System™ and Reduce Fracture Plating System™ Drill bit FITBONE® TROCHANTERIC Rodeo Telescopic Nail Contours Lapidus Plating System PORD DEVICE GUIDED GROWTH PLATE ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System TL-HEX Frame ID Charms OSCAR, MODEL OE3000DB LSP TITANIUM HUMERAL PLATE STAINLESS STEEL TIBIAL NAILING SYSTEM TL-HEX X-ray markers ANKLE HINDFOOT NAILING SYSTEM ANKLE COMPRESSION NAILING SYSTEM FITBONE® Transport and Lengthening System PERCUTANEOUS COMPRESSION PLATE (PC.CP) JPS JuniOrtho Plating System Orthofix Volar Distal Radial Plate JuniOrtho Plating System™ - Line extension

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device