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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 3 of 61
DeviceModel / ReferenceRegistriesClassStatus
Roi-C SI-ROIC-0117
FDA UDI
Class IIActive
Roi-A IR8211R
FDA UDI
Class IIActive
Avenue L IR7232P
FDA UDI
Class IIActive
Easyspine IB9020R
FDA UDI
Class IActive
Avenue L IR7134P
FDA UDI
Class IIActive
Vft VF9150R
FDA UDI
Class IIActive
Roi IR943R
FDA UDI
Class IIActive
Roi-A IR5337P
FDA UDI
Class IIActive
Mobi-C MB944R
FDA UDI
Class IActive
Vft VF9172R
FDA UDI
Class IIActive
SpineTune TL ST5508T-S
FDA UDI
Class IIActive
Roi-A IR5422P
FDA UDI
Class IIActive
Vft VF9028R
FDA UDI
Class IIActive
Easyspine ES952R
FDA UDI
Class IActive
Avenue L IR90051R
FDA UDI
Class IIActive
Roi-A IR2728P
FDA UDI
Class IIActive
Roi-C CMC1434P
FDA UDI
Class IIActive
Easyspine ES141T
FDA UDI
Class IIActive
SpineTune TL ST5512T-S
FDA UDI
Class IIActive
Roi-T IR9062R
FDA UDI
Class IActive
Avenue L EC120T
FDA UDI
Class IActive
Roi-A IR8333R
FDA UDI
Class IIActive
FacetBRIDGE FS9051R
FDA UDI
Class IActive
SpineTune TL ST3404T
FDA UDI
Class IIActive
Avenue L IR90477R
FDA UDI
Class IIActive
Avenue L EC008R
FDA UDI
Class IActive
Roi-A IR9299R
FDA UDI
Class IIActive
Roi-T IR9021R
FDA UDI
Class IIActive
Roi-C MC9016R
FDA UDI
Class IIActive
SpineTune TL ST3103T
FDA UDI
Class IIActive
Roi-T IR9145R
FDA UDI
Class IActive
Roi-T IR9040R
FDA UDI
Class IActive
SpineTune TL ST1016T-S
FDA UDI
Class IIActive
Vft VF9159R
FDA UDI
Class IIActive
Easyspine ES861T
FDA UDI
Class IIActive
Avenue L IR90180R
FDA UDI
Class IIActive
Roi-A IR5413P
FDA UDI
Class IIActive
Roi-T IR3674P
FDA UDI
Class IIActive
Avenue T AT990D
FDA UDI
Class IActive
Easyspine ES181T
FDA UDI
Class IIActive
Avenue L IR90224R
FDA UDI
Class IIActive
Avenue L IR6636P
FDA UDI
Class IIActive
Roi-C MC9022R
FDA UDI
Class IIActive
Roi-T IR9138R
FDA UDI
Class IActive
SpineTune TL ST7353T-S
FDA UDI
Class IIActive
Mc+ MC633P
FDA UDI
Class IIActive
Roi-C SI-ROIC-0114
FDA UDI
Class IIActive
Easyspine ES167T
FDA UDI
Class IIActive
Roi-A IR5343P
FDA UDI
Class IIActive
C-Plate CP0054T
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