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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

Country
US
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Catalogue (3026)

Page 14 of 61
DeviceModel / ReferenceRegistriesClassStatus
Mc+ MC351P
FDA UDI
Class IIActive
Avenue L IR6310P
FDA UDI
Class IIActive
SpineTune TL ST5504T-S
FDA UDI
Class IIActive
Mc+ MC909R
FDA UDI
Class IIActive
Vft VF9142R
FDA UDI
Class IIActive
Avenue L IR90218R
FDA UDI
Class IIActive
SpineTune TL ST5414T-S
FDA UDI
Class IIActive
Roi-A IR2532P
FDA UDI
Class IIActive
Avenue L IR90457R
FDA UDI
Class IActive
Avenue L IR6614P
FDA UDI
Class IIActive
Roi-C CMC1416P
FDA UDI
Class IIActive
VerteFIT VF9109R
FDA UDI
Class IIActive
Roi-A IR5324P
FDA UDI
Class IIActive
Avenue L IR6472P
FDA UDI
Class IIActive
Roi IR112P
FDA UDI
Class IIActive
SpineTune TL ST9040R
FDA UDI
Class IActive
Roi-A IR9204R
FDA UDI
Class IActive
Easyspine ES936R
FDA UDI
Class IActive
Avenue L IR6908P
FDA UDI
Class IIActive
Roi-T IR9140R
FDA UDI
Class IActive
Roi-T IR9038R
FDA UDI
Class IActive
FacetBRIDGE FS5520T
FDA UDI
UActive
FacetBRIDGE FS9021R
FDA UDI
Class IActive
SpineTune TL ST5426T-S
FDA UDI
Class IIActive
Avenue L IR90074R
FDA UDI
Class IIActive
Roi-A IR2627P
FDA UDI
Class IIActive
General instrumentation IG014R
FDA UDI
Class IActive
Roi-A IR8269R
FDA UDI
Class IIActive
Avenue L IR7074P
FDA UDI
Class IIActive
Roi-A IR5214P
FDA UDI
Class IIActive
Easyspine ES872T
FDA UDI
Class IIActive
SpineTune TL ST1004T-S
FDA UDI
Class IIActive
Roi-T IR9013R
FDA UDI
Class IIActive
FacetBRIDGE FS9052R
FDA UDI
Class IActive
Roi-A IR4411P
FDA UDI
Class IIActive
Avenue L IR90175R
FDA UDI
Class IIActive
Easyspine ES034T
FDA UDI
Class IIActive
General instrumentation IG032R
FDA UDI
Class IActive
Roi-T IR9067R
FDA UDI
Class IActive
Avenue L IR90065R
FDA UDI
Class IIActive
Roi-A IR2511P
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB9068R
FDA UDI
Class IIIActive
Roi-A IR4214P
FDA UDI
Class IIActive
Roi-A IR5327P
FDA UDI
Class IIActive
Mc+ MC910R
FDA UDI
Class IIActive
Roi IR901R
FDA UDI
Class IIActive
Roi-A IR8330R
FDA UDI
Class IIActive
FacetBRIDGE FS4515W
FDA UDI
UActive
Vft VF9033R
FDA UDI
Class IIActive
SpineTune TL ST9051R
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