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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 13 of 61
DeviceModel / ReferenceRegistriesClassStatus
SpineTune TL ST3102T-S
FDA UDI
Class IIActive
Vft VF2322P
FDA UDI
Class IIActive
Avenue L IR6830P
FDA UDI
Class IIActive
Roi-T IR9130R
FDA UDI
Class IIActive
Roi-A IR9388R
FDA UDI
Class IIActive
SpineTune TL ST1103T
FDA UDI
Class IIActive
Easyspine ES1120T
FDA UDI
Class IIActive
Roi-C CMC1441P
FDA UDI
Class IIActive
Avenue L IR90181R
FDA UDI
Class IIActive
Avenue L IR6534P
FDA UDI
Class IIActive
Vft VF1320P
FDA UDI
Class IIActive
Avenue T AT9063R
FDA UDI
Class IIActive
Roi-A IR8293R
FDA UDI
Class IIActive
Easyspine ES530T
FDA UDI
Class IIActive
Roi-C MC9112R
FDA UDI
Class IIActive
SpineTune TL ST1015T
FDA UDI
Class IIActive
Avenue L IR90214R
FDA UDI
Class IIActive
SpineTune TL ST5409T-S
FDA UDI
Class IIActive
Roi IR918R
FDA UDI
Class IIActive
SpineTune TL ST1464T-S
FDA UDI
Class IIActive
Avenue T AT0055P
FDA UDI
Class IIActive
Roi-C CMC1342P
FDA UDI
Class IIActive
SpineTune TL ST7254T-S
FDA UDI
Class IIActive
Roi-C MC1322P
FDA UDI
Class IIActive
Vft VF9166R
FDA UDI
Class IIActive
Avenue L SI-AVEL-0125
FDA UDI
Class IIActive
Roi IR937R
FDA UDI
Class IIActive
SpineTune TL ST9065R
FDA UDI
Class IActive
Avenue L EC460T
FDA UDI
Class IActive
Avenue L IR90006R
FDA UDI
Class IActive
Roi-A IR9280R
FDA UDI
Class IIActive
Vft VF3224P
FDA UDI
Class IIActive
Easyspine ES9005R
FDA UDI
Class IActive
Avenue L IR6930P
FDA UDI
Class IIActive
Avenue L IR90028R
FDA UDI
Class IIActive
SpineTune TL ST1204T-S
FDA UDI
Class IIActive
Roi-A IR5229P
FDA UDI
Class IIActive
General instrumentation IG017R
FDA UDI
Class IActive
Roi-A IR5238P
FDA UDI
Class IIActive
Roi-C CMC1445P
FDA UDI
Class IIActive
Roi-A IR8305R
FDA UDI
Class IIActive
Roi-A IR2628P
FDA UDI
Class IIActive
Avenue L IR90081R
FDA UDI
Class IIActive
Roi-T IR3643P
FDA UDI
Class IIActive
Avenue L IR6552P
FDA UDI
Class IIActive
Avenue L IR7110P
FDA UDI
Class IIActive
Roi-A IR5321P
FDA UDI
Class IIActive
Easyspine ES630T
FDA UDI
Class IIActive
Roi-T IR8674T
FDA UDI
Class IIActive
Avenue T AT9035R
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