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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 18 of 61
DeviceModel / ReferenceRegistriesClassStatus
Roi-T IR9141R
FDA UDI
Class IActive
Avenue L IR6268P
FDA UDI
Class IIActive
Roi-A IR2736P
FDA UDI
Class IIActive
Avenue T AT0014P
FDA UDI
Class IIActive
Mc+ MC901R
FDA UDI
Class IIActive
Roi-T IR9025R
FDA UDI
Class IActive
Avenue L IR6512P
FDA UDI
Class IIActive
Avenue L IR90185R
FDA UDI
Class IIActive
Roi-A IR5127P
FDA UDI
Class IIActive
Easyspine ES1119T
FDA UDI
Class IIActive
Roi-C MC9088R
FDA UDI
Class IActive
Avenue L IR6156P
FDA UDI
Class IIActive
Roi-A IR9339R
FDA UDI
Class IIActive
Mc+ MC653P
FDA UDI
Class IIActive
Roi-A IR9308R
FDA UDI
Class IIActive
Mc+ MC933R
FDA UDI
Class IIActive
Avenue L IR6214P
FDA UDI
Class IIActive
C-Plate CP0068T
FDA UDI
Class IIActive
Mc+ MC151P
FDA UDI
Class IIActive
Avenue T AT0058P
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB3577
FDA UDI
Class IIIActive
Mc+ MC310P
FDA UDI
Class IIActive
SpineTune TL ST2357T
FDA UDI
Class IIActive
Avenue L IR90511R
FDA UDI
Class IIActive
Roi-T IR3620P
FDA UDI
Class IIActive
Avenue L IR90494R
FDA UDI
Class IIActive
SpineTune TL ST1253T
FDA UDI
Class IIActive
Roi-A IR4442P
FDA UDI
Class IIActive
Avenue T AT9024R
FDA UDI
Class IActive
Easyspine ES043T
FDA UDI
Class IIActive
Easyspine ES9017R
FDA UDI
Class IActive
Roi-A IR9362R
FDA UDI
Class IIActive
Roi-T IR9042R
FDA UDI
Class IActive
Avenue L IR90134R
FDA UDI
Class IIActive
Roi-C MC1342P
FDA UDI
Class IIActive
Roi-A IR5331P
FDA UDI
Class IIActive
Roi-A IR4427P
FDA UDI
Class IIActive
SpineTune TL ST9037R
FDA UDI
Class IActive
Avenue L EC010R
FDA UDI
Class IActive
VerteFIT VF9118R
FDA UDI
Class IIActive
Vft VF3317P
FDA UDI
Class IIActive
Roi IR932R
FDA UDI
Class IIActive
SpineTune TL ST1105T-S
FDA UDI
Class IIActive
SpineTune TL ST3456T
FDA UDI
Class IIActive
Roi-A IR2621P
FDA UDI
Class IIActive
Roi-A IR4343P
FDA UDI
Class IIActive
Avenue L IR7016P
FDA UDI
Class IIActive
Avenue L EC990A
FDA UDI
Class IActive
Easyspine ES618T
FDA UDI
Class IIActive
Avenue L IR6832P
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