FDA Registration
Active
🇺🇸 United States
ORTHOFIX US LLC
Reg #: 2183449
·
FEI: 2183449
·
Expires 2026
Products
95
Proprietary Names
147
Establishment Types
5
Classifications
95
Registration Details
- Registration Name
- ORTHOFIX US LLC
- Registration Number
- 2183449
- FEI Number
- 2183449
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- ZIP
- 75056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051945
- PMA Number
- P210035
Owner / Operator
- Firm Name
- Orthofix US LLC
- Operator Number
- 10028162
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- Postal Code
- 75056
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-11-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-11-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-11-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-11-14 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2022-03-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-03-16 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2015-11-09 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-11-14 |
| Template | HWT | Class 1 | Orthopedic | No | 2009-08-31 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2009-01-05 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2016-01-11 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-11-14 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-09-07 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-09-07 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-09-07 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-09-07 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2015-09-24 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2025-11-20 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2020-04-02 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-05-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-05-19 |
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | Class 2 | Orthopedic | No | 2025-11-20 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2015-09-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-08-31 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2018-05-16 |
| Fork | HXE | Class 1 | Orthopedic | No | 2015-11-09 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2015-11-09 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-04-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 2009-08-31 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2009-08-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2015-11-09 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-11-20 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2025-11-20 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2015-11-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-11-20 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2009-08-31 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2015-09-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2025-11-20 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-11-20 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2025-11-20 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2009-08-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2009-08-31 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2009-08-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2009-01-05 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-11-20 |
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 2 | Orthopedic | No | 2022-05-09 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2009-08-31 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2009-08-31 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2015-09-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2009-08-31 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2015-11-09 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2009-08-31 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2009-08-31 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2025-11-20 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2025-11-20 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-11-20 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2015-11-09 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-08-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| System, Cement Removal Extraction | LZV | Class 2 | Orthopedic | No | 2025-11-20 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2025-11-20 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2015-10-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2015-11-09 |
| Bender | HXW | Class 1 | Orthopedic | No | 2009-08-31 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-11-09 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2009-08-31 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2015-09-24 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2025-09-29 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2015-09-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2009-08-31 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2016-12-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2009-08-31 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2015-11-09 |
Proprietary Names
MIOT plating system
TIBIAL NAILING SYSTEM
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma
Class I instrument
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3MM SINGLE AXIAL CONNECTOR
Electro-Biology
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
plate bone pediatric
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer
CONTOURS Proximal humeral plate
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
FIREBIRD SI Fusion System
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
BLACKSTONE SPINAL FIXATION SYSTEM
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
Connector System
M6-C Artificial Cervical Disc Instruments AS
Agile Nail
Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Pho
Navigated Instrument System
FIREBIRD SPINAL FIXATION SYSTEM
CONTOURS LAPIDUS PLATING SYSTEM
TrueLok Hexapod System (TL-HEX) V2
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
JPS JuniOrtho Plating System
JuniOrtho Plating System
SKYHAWK LATERAL PLATE SYSTEM
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
Azure Anterior Cervical Plate System
TrueLok Evo
KAWE stethoscope
EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL
FitboneTM Trochanteric
BLACKSTONE POSTERIOR CERVICAL SYSTEM
Atlas Spine Expandable Interbody System
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
BLACKSTONE SURGICAL TITANIUM MESH
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
BLACKSTONE SFS PARALLEL ROD CONNECTORS
FEMORAL NAILING SYTEM
AZURE ANTERIOR CERVICAL PLATE SYSTEM
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
IPY
Centurion POCT System
BLACKSTONE ASCENT MULTIAXIAL SCREWS
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
CETRA Anterior Cervical Plate System
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def
ORTHOFIX VOLAR DISTAL RADIAL PLATE
MJ-FLEX THE NEW METAIZEAU NAIL
Accelstim
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
ORTHOFIX MODULSYSTEM
FITBONE(R) TAA
CONTOURS VSP III VOLAR PLATING SYSTEM
REDUCE FRACTURE PLATING SYSTEM
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
GROWTH GUIDANCE PLATE
TrueLok Elevate
Firebird SI Navigation System
Cervical Stand Alone System
PILLAR SA Ti Spacer System
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
FORZA XP Expandable Spacer System
CENTURION POCT SYSTEM
SambaScrew 3D SI Fusion System
CHIMAERA Hip Fracture System - Trochanteric Nailing System
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
Physiostim and Spinalstim
FORZA Ti Spacer System
CERVICAL STAND ALONE SYSTEM
BLACKSTONE PILLAR XL PEEK SPACERS
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
BLACKSTONE PEDICLE SCREW SYSTEM
Guided Growth Plate System Plus
FORZA® XP Expandable Spacer System
plate fixation bone
Titanium Nailing System
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
G-Beam Fusion Beaming System
ankle hindfoot nailing system
BIOTRONIK torque wrench
O-Genesis Graft Delivery System
FITBONE® Transport and Lengthening System
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
FORZA PTC Spacer System
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR
RIVAL View Plating Systems and Reduce Fracture Plating Systems
Oscar 3
Cervicalstim
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
additional accessories for Orthofix system
FORZA SPACER SYSTEM
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
Galaxy UNYCO System
SKYHAWK INTERBODY FUSION SYSTEM
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
CONSTRUX Mini Ti Spacer System
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
FITBONE TAA
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
M6-C Single Use, Disposable Instrumentation
PILLAR SA PTC
GALAXY UNYCO DIAPHYSEAL TIBIA KIT
M6-C Artificial Cervical Disc
Galaxy Fixation System
CONSTRUX MINI PEEK TI SPACER SYSTEM
VIEW and REDUCE plating system
GUIDED GROWTH SYSTEM
Galaxy wrist
RODEO Telescopic Nail
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
BITE compression screw
Titanium humeral plating system LSP
CONSTRUX Mini PTC Spacer System
SOLE Medial Column Fusion Plate
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
Oscar 2
CONSTRUX Mini PEEK Spacer System
Fitbone Trochanteric
Medical device exempt
CONSTRUX MINI PEEK SPACER SYSTEM
CONSTRUX MINI PEEK VBR SYSTEM
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only