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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 7 of 61
DeviceModel / ReferenceRegistriesClassStatus
SpineTune TL ST3353T-S
FDA UDI
Class IIActive
Roi-A IR9331R
FDA UDI
Class IIActive
Roi-C MC1351P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0041
FDA UDI
Class IIActive
Roi-T IR8615T
FDA UDI
Class IIActive
Vft VF9141R
FDA UDI
Class IIActive
Mc+ MC354P
FDA UDI
Class IIActive
Roi IR925R
FDA UDI
Class IIActive
Avenue L IR6656P
FDA UDI
Class IIActive
SpineTune TL ST1251T-S
FDA UDI
Class IIActive
Easyspine ES9030R
FDA UDI
Class IActive
Roi-T IR3649P
FDA UDI
Class IIActive
SpineTune TL ST1355T-S
FDA UDI
Class IIActive
Easyspine ES9013R
FDA UDI
Class IActive
Easyspine ES173T
FDA UDI
Class IIActive
Vft VF1303P
FDA UDI
Class IIActive
SpineTune TL ST1402T-S
FDA UDI
Class IIActive
Roi-A IR4341P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0100
FDA UDI
Class IIActive
SpineTune TL ST1017T-S
FDA UDI
Class IIActive
SpineTune TL ST3453T-S
FDA UDI
Class IIActive
SpineTune TL ST3453T
FDA UDI
Class IIActive
Roi-A IR9432R
FDA UDI
Class IIActive
Avenue L IR6632P
FDA UDI
Class IIActive
Roi-C SI-ROIC-0002
FDA UDI
Class IIActive
Mc+ MC340P
FDA UDI
Class IIActive
Roi-A IR5212P
FDA UDI
Class IIActive
SpineTune TL ST3502T-S
FDA UDI
Class IIActive
FacetBRIDGE FS4517T
FDA UDI
UActive
Avenue L IR90066R
FDA UDI
Class IIActive
Roi-A IR5126P
FDA UDI
Class IIActive
Roi-A IR2543P
FDA UDI
Class IIActive
Avenue T AT9053R
FDA UDI
Class IIActive
Mc+ MC131P
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB9043R
FDA UDI
Class IIIActive
Vft VF3338P
FDA UDI
Class IIActive
SpineTune TL ST9054R
FDA UDI
Class IActive
Avenue L IR90012R
FDA UDI
Class IActive
VerteFIT VF991A-CR
FDA UDI
Class IActive
Easyspine ES9055R
FDA UDI
Class IActive
C-Plate CP2310T
FDA UDI
Class IIActive
Roi-A IR2411P
FDA UDI
Class IIActive
Roi-A IR8309R
FDA UDI
Class IIActive
Roi-C MC9108R
FDA UDI
Class IIActive
Roi-A IR2741P
FDA UDI
Class IIActive
SpineTune TL ST9048R
FDA UDI
Class IActive
Roi-A IR5417P
FDA UDI
Class IIActive
Roi-A IR9353R
FDA UDI
Class IIActive
Avenue L SI-AVEL-0079
FDA UDI
Class IIActive
Roi-A IR9394R
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