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Sign in to claim this brandOrthofix US LLC
US
Last updated September 17, 2026
What Orthofix US LLC makes
Orthofix US LLC manufactures metallic spinal interbody fusion cages, spinal fixation plates (non-bioabsorbable), and bone-screw internal fixation systems for spinal stabilization, including non-sterile variants. Their portfolio also includes growth-correction orthopaedic fixation plates, vertebral body prostheses (non-sterile), and sacroiliac joint fixation implants. Reusable manual surgical rotary handpieces are part of their surgical tooling offerings.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Orthofix US LLC manufacture?
Orthofix US LLC specializes in spinal and orthopaedic fixation devices. Their portfolio includes metallic spinal interbody fusion cages, bone-screw internal spinal fixation systems (both sterile and non-sterile), spinal fixation plates (non-bioabsorbable), growth-correction orthopaedic fixation plates, vertebral body prostheses (non-sterile), and sacroiliac joint fixation implants. These devices are designed for spinal stabilization, fusion, and correction procedures. The company also produces reusable manual surgical rotary handpieces for surgical applications.
Where is Orthofix US LLC based?
Orthofix US LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction for device authorization and reporting requirements.
Which regulatory registries or databases list Orthofix US LLC’s devices?
Orthofix US LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to access standardized identification information for their products. The UDI system is a key component of the FDA’s post-market surveillance efforts.
How are Orthofix US LLC’s devices classified under FDA regulations?
Orthofix US LLC’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and the body part involved. For example, spinal fixation plates and interbody cages are typically Class II due to their surgical nature and risk profile, whereas reusable handpieces may be Class I if they pose lower risk.
Why do some of Orthofix US LLC’s devices include ‘non-sterile’ in their description?
The ‘non-sterile’ designation indicates that certain devices are not pre-packaged in a sterile state and must be sterilized by the healthcare facility before use. This distinction is important for inventory management and surgical planning, as sterile devices are ready for immediate use, while non-sterile variants require additional processing (e.g., autoclaving) to ensure safety. Orthofix US LLC offers both sterile and non-sterile versions of specific devices like spinal fixation systems and vertebral body prostheses to cater to different clinical workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3451 Plano Parkway, Lewisville, TX, 75056
- Website
- orthofix.com
- —
- —
- [email protected]
- Phone
- +1(800)527-0404
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2183449
- DUNS Number
- 927083808
Catalogue (8519)
Page 28 of 171| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cetra | 19-0356 | FDA UDI | Class II | Active |
| Construx - Mini Peek Vbr | 47-4006 | FDA UDI | Class II | Active |
| Firebird | 44-3990 | FDA UDI | Class II | Active |
| Firebird | 44-5850 | FDA UDI | Class II | Active |
| Navigated Instruments;firebird Nxg | 36-1344 | FDA UDI | Class II | Active |
| Ascent | 65-1042 | FDA UDI | Class I | Active |
| Construx - Mini Ptc | 37-5108SP | FDA UDI | Class II | Active |
| Firebird | 44-5811 | FDA UDI | Class II | Active |
| Forza | 87-4810SP | FDA UDI | Class II | Active |
| Hallmark | 62-0031 | FDA UDI | Class I | Active |
| Firebird | 51-7061 | FDA UDI | Class II | Active |
| Pillar Tl | 45-7413 | FDA UDI | Class II | Active |
| Sfs | 57-0023 | FDA UDI | Class I | Active |
| Forza | 89-9806SP | FDA UDI | Class II | Active |
| Forza | 89-1806SP | FDA UDI | Class II | Active |
| Forza | 88-2010SP | FDA UDI | Class II | Active |
| Hallmark | 62-3010 | FDA UDI | Class II | Active |
| Phoenix | 20-4055 | FDA UDI | Class II | Active |
| Hallmark | 62-6125 | FDA UDI | Class II | Active |
| Forza | 89-3006SP | FDA UDI | Class II | Active |
| Centurion | 69-8203 | FDA UDI | Class I | Active |
| Forza | 89-9016SP | FDA UDI | Class II | Active |
| Forza | 89-0108 | FDA UDI | Class I | Active |
| Skyhawk | 27-2570 | FDA UDI | Class II | Active |
| Skyhawk | 27-1647 | FDA UDI | Class II | Active |
| Lonestar | 83-8348 | FDA UDI | Class I | Active |
| Cetra | 19-5012 | FDA UDI | Class II | Active |
| Firebird | 77-8665 BE | FDA UDI | Class II | Active |
| Icon | 54-4430 | FDA UDI | Class II | Active |
| Pillar Al | 48-3014 | FDA UDI | Class II | Active |
| Firebird | 51-4330 | FDA UDI | Class II | Active |
| Pillar Xl | 72-5114 | FDA UDI | Class II | Active |
| Construx - Peek Vbr | 45-3346 | FDA UDI | Class II | Active |
| Fenestrated Screws | 36-5650SP | FDA UDI | Class II | Active |
| Lonestar | 84-5608 | FDA UDI | Class II | Active |
| Skyhawk | 27-4509 | FDA UDI | Class II | Active |
| Cetra | 19-0119 | FDA UDI | Class II | Active |
| Skyhawk | 450427-0003 | FDA UDI | Class II | Active |
| Construx - Mini Ptc | 37-3007SP | FDA UDI | Class II | Active |
| Firebird | 77-7825 | FDA UDI | Class II | Active |
| Cetra | 19-0374 | FDA UDI | Class II | Active |
| Firebird | 44-5525 BE | FDA UDI | Class II | Active |
| Skyhawk | 27-2139 | FDA UDI | Class II | Active |
| Pillar Sa | 49-8214 | FDA UDI | Class II | Active |
| Firebird Sfs | 44-0106 | FDA UDI | Class I | Active |
| Forza | 87-1308SP | FDA UDI | Class II | Active |
| Construx -peek Vbr | 47-4108C | FDA UDI | Class II | Active |
| Firebird | 51-7040 | FDA UDI | Class II | Active |
| Skyhawk | 27-5436 | FDA UDI | Class I | Active |
| Cetra | 19-4515 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Orthofix US LLC has nine FDA recall records initiated between February 20, 2025, and November 3, 2025. The records include both open and classified statuses. Reasons cited involve labeling discrepancies, such as incorrect width and height measurements on intervertebral body fusion devices and polyaxial screws, as well as inconsistent labeling claims.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 3, 2025 | Z-0896-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Z-0893-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Z-0895-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Z-0894-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Z-0891-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Z-0892-2026 | — | open, classified | Labeling contains claims that are not consistently present. |
| Sep 19, 2025 | Z-0478-2026 | — | open, classified | Polyaxial screws do not meet performance standards. |
| Jun 24, 2025 | Z-2555-2025 | — | open, classified | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. |
| Feb 20, 2025 | Z-1432-2025 | — | open, classified | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |