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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 20 of 61
DeviceModel / ReferenceRegistriesClassStatus
Avenue L SI-AVEL-0084
FDA UDI
Class IIActive
Roi-A IR8302R
FDA UDI
Class IIActive
Avenue L SI-AVEL-0039
FDA UDI
Class IIActive
Vft VF9134R
FDA UDI
Class IIActive
Vft VF3339P
FDA UDI
Class IIActive
Roi-C SI-ROIC-0115
FDA UDI
Class IIActive
Roi-C CMC1355P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0111
FDA UDI
Class IIActive
Easyspine ES515T
FDA UDI
Class IIActive
Roi-C MC9086R
FDA UDI
Class IActive
Avenue L EC130T
FDA UDI
Class IActive
SpineTune TL ST7452T-S
FDA UDI
Class IIActive
Avenue L EC090T
FDA UDI
Class IActive
SpineTune TL ST5426T
FDA UDI
Class IIActive
Mc+ MC612P
FDA UDI
Class IIActive
Roi-C SI-ROIC-0005
FDA UDI
Class IIActive
SpineTune TL ST5403T-S
FDA UDI
Class IIActive
InterBRIDGE IB9031R
FDA UDI
Class IActive
Avenue L IR90133R
FDA UDI
Class IIActive
Easyspine ES412T
FDA UDI
Class IIActive
Mc+ MC651P
FDA UDI
Class IIActive
SpineTune TL ST2355T-S
FDA UDI
Class IIActive
Easyspine ES168T
FDA UDI
Class IIActive
Avenue T AT9011R
FDA UDI
Class IActive
Roi-A IR2536P
FDA UDI
Class IIActive
Easyspine ES074T
FDA UDI
Class IIActive
Roi-A IR2425P
FDA UDI
Class IIActive
Roi-T IR9127R
FDA UDI
Class IIActive
SpineTune TL ST1357T-S
FDA UDI
Class IIActive
SpineTune TL ST9017R
FDA UDI
Class IActive
SpineTune TL ST1013T
FDA UDI
Class IIActive
Avenue L EC011R
FDA UDI
Class IActive
Roi-A IR9325R
FDA UDI
Class IIActive
Roi-A IR9351R
FDA UDI
Class IIActive
Avenue T AT9060R
FDA UDI
Class IIActive
SpineTune TL ST7256T-S
FDA UDI
Class IIActive
Roi-A IR8311R
FDA UDI
Class IIActive
SpineTune TL ST1554T-S
FDA UDI
Class IIActive
Roi-A IR9400R
FDA UDI
Class IIActive
Avenue L IR6436P
FDA UDI
Class IIActive
SpineTune TL ST3555T-S
FDA UDI
Class IIActive
Roi-A IR9389R
FDA UDI
Class IIActive
FacetBRIDGE FS4540T
FDA UDI
UActive
Mc+ MC324P
FDA UDI
Class IIActive
Vft VF9180R
FDA UDI
Class IIActive
Mc+ MC622P
FDA UDI
Class IIActive
Mc+ MC111P
FDA UDI
Class IIActive
Roi-A IR8202R
FDA UDI
Class IIActive
Vft VF3334P
FDA UDI
Class IIActive
SpineTune TL ST6353T-S
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