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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 5 of 61
DeviceModel / ReferenceRegistriesClassStatus
Avenue L IR90034R
FDA UDI
Class IIActive
Roi-A IR8217R
FDA UDI
Class IIActive
Roi-T IR8618T
FDA UDI
Class IIActive
Roi-A IR2442P
FDA UDI
Class IIActive
Easyspine ES032T
FDA UDI
Class IIActive
Easyspine ES005T
FDA UDI
Class IIActive
Mc+ MC741P
FDA UDI
Class IIActive
Easyspine ES504T
FDA UDI
Class IIActive
Avenue L IR90510R
FDA UDI
Class IIActive
Avenue L IR90050R
FDA UDI
Class IIActive
Roi-A IR5315P
FDA UDI
Class IIActive
Easyspine ES610T
FDA UDI
Class IIActive
Roi-T IR9041R
FDA UDI
Class IActive
Avenue L IR90015R
FDA UDI
Class IActive
FacetBRIDGE FS5530W
FDA UDI
UActive
Roi-A IR8275R
FDA UDI
Class IIActive
Avenue L IR6250P
FDA UDI
Class IIActive
Easyspine ES604T
FDA UDI
Class IIActive
Roi-A IR2443P
FDA UDI
Class IIActive
Easyspine ES033T
FDA UDI
Class IIActive
Avenue L IR90233R
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB3377
FDA UDI
Class IIIActive
Roi-A IR9378R
FDA UDI
Class IIActive
Avenue L SI-AVEL-0082
FDA UDI
Class IIActive
Avenue L IR90474R
FDA UDI
Class IIActive
Avenue L IR90172R
FDA UDI
Class IIActive
Avenue L IR90482R
FDA UDI
Class IIActive
Avenue L IR6430P
FDA UDI
Class IIActive
Roi-C MC9105R
FDA UDI
Class IIActive
Avenue L IR90179R
FDA UDI
Class IIActive
Roi IR927R
FDA UDI
Class IIActive
Avenue L IR90465R
FDA UDI
Class IIActive
Roi-A IR5217P
FDA UDI
Class IIActive
Avenue T AT9068R
FDA UDI
Class IIActive
Roi-C CMC1413P
FDA UDI
Class IIActive
SpineTune TL ST7357T-S
FDA UDI
Class IIActive
Avenue L IR90127R
FDA UDI
Class IIActive
FacetBRIDGE FS9030R
FDA UDI
Class IActive
SpineTune TL ST5440T-S
FDA UDI
Class IIActive
Mc+ MC914R
FDA UDI
Class IIActive
Roi-T IR9083R
FDA UDI
Class IActive
Vft VF9178R
FDA UDI
Class IIActive
Vft VF9102R
FDA UDI
Class IIActive
Avenue L IR90103R
FDA UDI
Class IIActive
Roi-C MC9018R
FDA UDI
Class IIActive
VerteFIT VF9192R
FDA UDI
Class IIActive
Avenue L IR6874P
FDA UDI
Class IIActive
Avenue L IR7012P
FDA UDI
Class IIActive
Avenue L IR90055R
FDA UDI
Class IIActive
Avenue L EC021R
FDA UDI
Class IActive

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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