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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 16 of 61
DeviceModel / ReferenceRegistriesClassStatus
SpineTune TL ST9032R
FDA UDI
Class IActive
Avenue L SI-AVEL-0126
FDA UDI
Class IIActive
Avenue L IR90030R
FDA UDI
Class IIActive
Roi-C SI-ROIC-0038
FDA UDI
Class IIActive
Avenue L SI-AVEL-0080
FDA UDI
Class IIActive
General instrumentation IG004R
FDA UDI
Class IActive
Roi-T IR9022R
FDA UDI
Class IActive
Avenue L IR90173R
FDA UDI
Class IIActive
Easyspine ES183T
FDA UDI
Class IIActive
Easyspine ES9002R
FDA UDI
Class IActive
Avenue L IR90464R
FDA UDI
Class IIActive
Avenue L IR6808P
FDA UDI
Class IIActive
Mobi-C MB945R
FDA UDI
Class IActive
Avenue L IR90057R
FDA UDI
Class IIActive
Avenue L IR90099R
FDA UDI
Class IActive
Roi-A IR4336P
FDA UDI
Class IIActive
FacetBRIDGE FS5515W
FDA UDI
UActive
Avenue L IR90003R
FDA UDI
Class IActive
Avenue L IR90004R
FDA UDI
Class IActive
Roi-A IR8280R
FDA UDI
Class IIActive
SpineTune TL ST2256T
FDA UDI
Class IIActive
Mobi-C® Plug & Fit US MB9014R
FDA UDI
Class IIIActive
Roi-A IR4436P
FDA UDI
Class IIActive
SpineTune TL ST3253T-S
FDA UDI
Class IIActive
SpineTune TL ST1451T
FDA UDI
Class IIActive
Avenue T AT0027P
FDA UDI
Class IIActive
Roi-C MC9123R
FDA UDI
Class IIActive
Roi-T IR3644P
FDA UDI
Class IIActive
Vft VF9005R
FDA UDI
Class IIActive
Vft VF2233P
FDA UDI
Class IIActive
Roi-A IR5221P
FDA UDI
Class IIActive
FacetBRIDGE FS5550T
FDA UDI
UActive
C-Plate CP0050T
FDA UDI
Class IIActive
Easyspine ES603T
FDA UDI
Class IIActive
Avenue L SI-AVEL-0141
FDA UDI
Class IIActive
Mc+ MC744P
FDA UDI
Class IIActive
Roi-A IR9336R
FDA UDI
Class IIActive
Roi-A IR4335P
FDA UDI
Class IIActive
Avenue L IR90044R
FDA UDI
Class IIActive
Roi-T IR8642T
FDA UDI
Class IIActive
Avenue L IR7210P
FDA UDI
Class IIActive
General instrumentation IG046R
FDA UDI
Class IActive
Avenue L IR6252P
FDA UDI
Class IIActive
Easyspine ES865T
FDA UDI
Class IIActive
SpineTune TL ST9002R
FDA UDI
Class IActive
Avenue L SI-AVEL-0104
FDA UDI
Class IIActive
Vft VF9156R
FDA UDI
Class IIActive
Roi-T IR8644T
FDA UDI
Class IIActive
SpineTune TL ST9041R
FDA UDI
Class IActive
Mobi-C® Plug & Fit US MB3375
FDA UDI
Class IIIActive

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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