ORTHOFIX SRL

FDA Device Registration & Listing · BUSSOLENGO Verona, IT · Registration 9680825

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9680825
FEI Number
3002807827
Entity Name
ORTHOFIX SRL
City/State/Country
BUSSOLENGO Verona, IT
Establishment Address
VIA DELLE NAZIONI 9, BUSSOLENGO Verona 37012, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ORTHOFIX SRL (Owner Number: 9011783)
Owner / Operator Contact Address
VIA DELLE NAZIONI 9, --, BUSSOLENGO, IT-VR 37012, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101936
PMA Number
N/A

All Registered 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 Rival Reduce Fracture Plating System Rival View Plating System FLEXIBLE REAMER FLEXIBLE REAMER SYSTEM GUIDED GROWTH PLATE SYSTEM GUIDED GROWTH SYSTEM Galaxy UNYCO 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-05-25
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2007-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-11-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-11-17
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2013-01-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-01-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-05-11
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2017-05-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-06-15
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2022-04-20
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2024-06-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-06
HXC Wrench Orthopedic Class 1 888.4540 2024-03-25
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-04-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-07-03
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-05-10
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2007-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-12-11
IXJ Grid, Radiographic Radiology Class 1 892.1910 2025-04-16
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-06-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-12-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-11-25
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-11-25
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2024-03-25
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-01-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2000-04-06
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2015-11-06
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2010-12-27
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2020-03-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2005-11-25
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-12-30
LZV System, Cement Removal Extraction Orthopedic Class 2 888.4580 2016-12-13
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2016-12-13
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2007-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-05-18
LZV System, Cement Removal Extraction Orthopedic Class 2 888.4580 2018-05-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2007-12-21
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2024-06-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-10-28
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2018-01-10
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2023-11-07
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-12-06
HXX Screwdriver Orthopedic Class 1 888.4540 2024-05-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-06-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-06
HTO Reamer Orthopedic Class 1 888.4540 2007-05-14
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2015-11-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-10-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-05-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-04-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-05-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-03

Official Correspondent

ELVIRA TACCARELLI

US Agent Details

Amira Milutinovic Business: ORTHOFIX LLC Email: AmiraMilutinovic@Orthofix.com Phone: (214) 9372196

Related Public Records

Same Entity

ORTHOFIX SRL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680825. Last updated year: 2026. Please use registration number 9680825 when referencing this establishment in official correspondence.
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