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Sign in to claim this brandLdr Spine USA
US
Last updated May 23, 2026
What Ldr Spine USA makes
Ldr Spine USA manufactures spinal implant devices, including polymeric and metal-polymer composite spinal fusion cages, bone-screw internal fixation systems (both sterile and non-sterile), reusable surgical implant templates, and reusable bone tools like levers, elevators, and files. Their portfolio also includes spinal implant trial devices and specific product lines such as the C-Plate, ROI-A, ROI-C, ROI-T, Avenue L, and FacetBRIDGE.
The company’s devices are regulated under FDA classifications including Class I, Class II, Class III, and Unclassified (U), with all products listed in the FDA’s Unique Device Identifier (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 Ldr Spine USA manufacture?
Ldr Spine USA specializes in spinal implant devices. Their portfolio includes polymeric spinal fusion cages, metal-polymer composite spinal interbody fusion cages, bone-screw internal spinal fixation systems (both sterile and non-sterile), reusable surgical implant templates, and reusable bone tools such as levers, elevators, and files. They also produce spinal implant trial devices and specific product lines like the C-Plate, ROI-A, ROI-C, ROI-T, Avenue L, and FacetBRIDGE.
Where is Ldr Spine USA based?
Ldr Spine USA is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).
Which regulatory registries list Ldr Spine USA’s devices?
Ldr Spine USA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each product, allowing healthcare providers and regulators to identify and verify the devices in use.
How are Ldr Spine USA’s devices classified under FDA regulations?
Ldr Spine USA’s devices fall under multiple FDA classifications, including Class I, Class II, Class III, and Unclassified (U). The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, reusable surgical tools like bone files or templates may be Class I, while spinal fusion cages or fixation systems could be Class II or III due to their higher risk profiles.
Why do some of Ldr Spine USA’s devices have different sterility classifications?
Ldr Spine USA’s devices are categorized as either sterile or non-sterile based on their intended use and manufacturing processes. Sterile devices, such as polymeric spinal fusion cages or bone-screw fixation systems, are designed for direct implantation into the body and must meet stringent sterilization standards to prevent infection. Non-sterile devices, like reusable bone tools, are intended for single-use in sterile environments or are cleaned and reused, reducing the need for terminal sterilization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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Catalogue (3026)
Page 6 of 61| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mc+ | MC942R | FDA UDI | Class II | Active |
| Avenue L | IR90108R | FDA UDI | Class II | Active |
| Avenue T | AT9007R | FDA UDI | Class I | Active |
| Roi-C | MC1435P | FDA UDI | Class II | Active |
| Roi-A | IR5246P | FDA UDI | Class II | Active |
| SpineTune TL | ST6457T-S | FDA UDI | Class II | Active |
| Avenue L | EC020R | FDA UDI | Class I | Active |
| Roi-C | CMC1356P | FDA UDI | Class II | Active |
| Roi | IR936R | FDA UDI | Class II | Active |
| Vft | VF1321P | FDA UDI | Class II | Active |
| SpineTune TL | ST1201T | FDA UDI | Class II | Active |
| Roi-A | IR2525P | FDA UDI | Class II | Active |
| Roi-C | SI-ROIC-0001 | FDA UDI | Class II | Active |
| Mobi-C Plug & Fit | MB992 | FDA UDI | Class I | Active |
| Mobi-C Plug & Fit | MB9075R | FDA UDI | Class I | Active |
| Easyspine | ES052T | FDA UDI | Class II | Active |
| Avenue L | IR7228P | FDA UDI | Class II | Active |
| Avenue T | AT0068P | FDA UDI | Class II | Active |
| SpineTune TL | ST6355T-S | FDA UDI | Class II | Active |
| Avenue L | IR6414P | FDA UDI | Class II | Active |
| Roi-T | IR3614P | FDA UDI | Class II | Active |
| Roi-A | IR8270R | FDA UDI | Class II | Active |
| SpineTune TL | ST1463T-S | FDA UDI | Class II | Active |
| Roi-A | IR9332R | FDA UDI | Class II | Active |
| Easyspine | ES9037R | FDA UDI | Class I | Active |
| Roi-C | MC1441P | FDA UDI | Class II | Active |
| Roi-C | CMC1323P | FDA UDI | Class II | Active |
| Roi-A | IR4441P | FDA UDI | Class II | Active |
| C-Plate | CP0064T | FDA UDI | Class II | Active |
| C-Plate | CP0028T | FDA UDI | Class II | Active |
| Mc+ | MC754P | FDA UDI | Class II | Active |
| Mc+ | MC133P | FDA UDI | Class II | Active |
| Mc+ | MC722P | FDA UDI | Class II | Active |
| Easyspine | ES1129T | FDA UDI | Class II | Active |
| General instrumentation | IG019R | FDA UDI | Class I | Active |
| Easyspine | ES407T | FDA UDI | Class II | Active |
| Roi-A | IR8277R | FDA UDI | Class II | Active |
| SpineTune TL | ST9003R | FDA UDI | Class I | Active |
| Roi-A | IR9343R | FDA UDI | Class II | Active |
| Roi-T | IR9096R | FDA UDI | Class I | Active |
| Roi-C | CMC1452P | FDA UDI | Class II | Active |
| Roi-A | IR5243P | FDA UDI | Class II | Active |
| Roi-A | IR8257R | FDA UDI | Class II | Active |
| Avenue L | IR7136P | FDA UDI | Class II | Active |
| Avenue L | IR90497R | FDA UDI | Class I | Active |
| SpineTune TL | ST3456T-S | FDA UDI | Class II | Active |
| Easyspine | ES612T | FDA UDI | Class II | Active |
| Mobi-C® Plug & Fit US | MB3355 | FDA UDI | Class III | Active |
| Vft | VF3225P | FDA UDI | Class II | Active |
| Avenue L | IR90011R | FDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 29, 2016 | Z-0045-2017 | — | terminated | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury |