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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 19 of 61
DeviceModel / ReferenceRegistriesClassStatus
Avenue L IR6152P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0105
FDA UDI
Class IIActive
Roi-C MC9128R
FDA UDI
Class IIActive
Roi IR907R
FDA UDI
Class IActive
Easyspine ES410T
FDA UDI
Class IIActive
Vft VF9112R
FDA UDI
Class IIActive
SpineTune TL ST1103T-S
FDA UDI
Class IIActive
Mc+ MC350P
FDA UDI
Class IIActive
SpineTune TL ST1402T
FDA UDI
Class IIActive
Avenue L IR90049R
FDA UDI
Class IIActive
Roi-A IR2622P
FDA UDI
Class IIActive
SpineTune TL ST9015R
FDA UDI
Class IActive
Mobi-C® Plug & Fit US MB9045R
FDA UDI
Class IIIActive
Mobi-C MB3996
FDA UDI
Class IIIActive
Roi-A IR5118P
FDA UDI
Class IIActive
Vft VF1311P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0110
FDA UDI
Class IIActive
Easyspine ES9015R
FDA UDI
Class IActive
Roi-C MC9117R
FDA UDI
Class IIActive
Easyspine ES923R
FDA UDI
Class IActive
Roi IR102P
FDA UDI
Class IIActive
Avenue L IR90080R
FDA UDI
Class IIActive
Avenue L IR90487R
FDA UDI
Class IIActive
Mc+ MC752P
FDA UDI
Class IIActive
Avenue T AT0023P
FDA UDI
Class IIActive
Avenue T AT0022P
FDA UDI
Class IIActive
C-Plate CP0024T
FDA UDI
Class IIActive
Avenue L IR90170R
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB9029R
FDA UDI
Class IIIActive
SpineTune TL ST9052R
FDA UDI
Class IActive
Avenue L IR90247R
FDA UDI
Class IIActive
Vft VF3332P
FDA UDI
Class IIActive
Roi-C CMC1414P
FDA UDI
Class IIActive
Avenue L IR6550P
FDA UDI
Class IIActive
Mc+ MC726P
FDA UDI
Class IIActive
Roi IR946R
FDA UDI
Class IActive
SpineTune TL ST7252T-S
FDA UDI
Class IIActive
Mc+ MC326P
FDA UDI
Class IIActive
FacetBRIDGE FS9081R
FDA UDI
Class IActive
SpineTune TL ST3454T
FDA UDI
Class IIActive
SpineTune TL ST9001R
FDA UDI
Class IActive
Easyspine ES1106T
FDA UDI
Class IIActive
Avenue L IR90207R
FDA UDI
Class IIActive
Easyspine ES505T
FDA UDI
Class IIActive
Avenue L SI-AVEL-0117
FDA UDI
Class IIActive
Easyspine ES509T
FDA UDI
Class IIActive
General instrumentation IG023R
FDA UDI
Class IActive
Easyspine ES9029R
FDA UDI
Class IActive
Roi-A IR8210R
FDA UDI
Class IIActive
Roi-A IR8282R
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