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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 2 of 61
DeviceModel / ReferenceRegistriesClassStatus
Avenue L IR90143R
FDA UDI
Class IIActive
Avenue T AT990C
FDA UDI
Class IActive
Mc+ MC342P
FDA UDI
Class IIActive
Roi-T IR3673P
FDA UDI
Class IIActive
Roi-A IR4445P
FDA UDI
Class IIActive
Avenue L SI-AVEL-0119
FDA UDI
Class IIActive
SpineTune TL ST6255T-S
FDA UDI
Class IIActive
Roi-A IR9284R
FDA UDI
Class IIActive
Avenue L IR90118R
FDA UDI
Class IIActive
Vft VF2225P
FDA UDI
Class IIActive
Roi-C MC9040R
FDA UDI
Class IIActive
FacetBRIDGE FS9022R
FDA UDI
Class IActive
Avenue L IR6114P
FDA UDI
Class IIActive
General instrumentation IG041R
FDA UDI
Class IActive
Roi-C SI-ROIC-0018
FDA UDI
Class IIActive
Avenue L IR90165R
FDA UDI
Class IIActive
FacetBRIDGE FS4550T
FDA UDI
UActive
Roi-A IR2632P
FDA UDI
Class IIActive
Avenue T AT9015R
FDA UDI
Class IActive
Roi-C MC1320P
FDA UDI
Class IIActive
Roi-A IR2615P
FDA UDI
Class IIActive
C-Plate CP2316T
FDA UDI
Class IIActive
Avenue T AT0033P
FDA UDI
Class IIActive
General instrumentation IG027R
FDA UDI
Class IActive
Roi-A IR9374R
FDA UDI
Class IIActive
Easyspine ES9035R
FDA UDI
Class IActive
Avenue L IR90191R
FDA UDI
Class IIActive
Mc+ MC960R
FDA UDI
Class IIActive
Mc+ MC322P
FDA UDI
Class IIActive
Avenue T AT9014R
FDA UDI
Class IActive
Mc+ MC736P
FDA UDI
Class IIActive
Roi-A IR8287R
FDA UDI
Class IIActive
Avenue L IR90036R
FDA UDI
Class IIActive
Roi-A IR8219R
FDA UDI
Class IIActive
Roi-A IR8238R
FDA UDI
Class IIActive
SpineTune TL ST5405T-S
FDA UDI
Class IIActive
Easyspine ES954R
FDA UDI
Class IActive
Vft VF9131R
FDA UDI
Class IIActive
Roi-C CMC1336P
FDA UDI
Class IIActive
Roi-A IR9330R
FDA UDI
Class IIActive
Roi-C CMC1426P
FDA UDI
Class IIActive
General instrumentation IG001R
FDA UDI
Class IActive
Avenue L IR90084R
FDA UDI
Class IIActive
Roi-A IR9341R
FDA UDI
Class IIActive
SpineTune TL ST9009R
FDA UDI
Class IActive
Roi IR915R
FDA UDI
Class IIActive
FacetBRIDGE FS9050R
FDA UDI
Class IActive
Roi-T IR3680P
FDA UDI
Class IIActive
Avenue L IR6608P
FDA UDI
Class IIActive
SpineTune TL ST5411T-S
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