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Ldr 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

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US
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Catalogue (3026)

Page 4 of 61
DeviceModel / ReferenceRegistriesClassStatus
Roi-C MC9019R
FDA UDI
Class IIActive
SpineTune TL ST1101T
FDA UDI
Class IIActive
InterBRIDGE IB0014T
FDA UDI
Class IIActive
Roi-A IR4325P
FDA UDI
Class IIActive
SpineTune TL ST3402T-S
FDA UDI
Class IIActive
Roi IR906R
FDA UDI
Class IActive
Roi-A IR9437R
FDA UDI
Class IIActive
Avenue L IR90131R
FDA UDI
Class IIActive
Mc+ MC132P
FDA UDI
Class IIActive
Roi-A IR5326P
FDA UDI
Class IIActive
Roi-A IR4326P
FDA UDI
Class IIActive
Roi-A IR92003R
FDA UDI
Class IIActive
Roi-C CMC1444P
FDA UDI
Class IIActive
Roi-C MC9001R
FDA UDI
Class IIActive
Mc+ MC710P
FDA UDI
Class IIActive
SpineTune TL ST6455T-S
FDA UDI
Class IIActive
SpineTune TL ST3101T-S
FDA UDI
Class IIActive
Easyspine ES645T
FDA UDI
Class IIActive
Easyspine ES176T
FDA UDI
Class IIActive
General instrumentation IG013R
FDA UDI
Class IActive
Avenue L IR90013R
FDA UDI
Class IActive
Roi-A IR2432P
FDA UDI
Class IIActive
Easyspine ES9034R
FDA UDI
Class IActive
Avenue L SI-AVEL-0109
FDA UDI
Class IIActive
Avenue L IR90227R
FDA UDI
Class IIActive
SpineTune TL ST5470T-S
FDA UDI
Class IIActive
Easyspine ES030T
FDA UDI
Class IIActive
Easyspine ES1110T
FDA UDI
Class IIActive
Avenue L IR90468R
FDA UDI
Class IIActive
Avenue L IR90149R
FDA UDI
Class IIActive
Mc+ MC731P
FDA UDI
Class IIActive
SpineTune TL ST5430T-S
FDA UDI
Class IIActive
SpineTune TL ST1456T-S
FDA UDI
Class IIActive
Roi-A IR5332P
FDA UDI
Class IIActive
Roi-A IR8254R
FDA UDI
Class IIActive
Vft VF1312P
FDA UDI
Class IIActive
Roi-C MC1316P
FDA UDI
Class IIActive
Avenue L IR90016R
FDA UDI
Class IActive
Roi-A IR9391R
FDA UDI
Class IIActive
Vft VF9147R
FDA UDI
Class IIActive
Roi IR926R
FDA UDI
Class IIActive
Avenue L IR90145R
FDA UDI
Class IIActive
SpineTune TL ST1252T-S
FDA UDI
Class IIActive
Avenue L IR90478R
FDA UDI
Class IIActive
SpineTune TL ST5404T-S
FDA UDI
Class IIActive
SpineTune TL ST5424T
FDA UDI
Class IIActive
Avenue L IR6470P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0122
FDA UDI
Class IIActive
Roi-C MC9122R
FDA UDI
Class IIActive
Easyspine ES403T
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
Aug 29, 2016Z-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