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Sign in to claim this brandEMINENT SPINE LLC
US
Last updated May 23, 2026
What EMINENT SPINE LLC makes
EMINENT SPINE LLC manufactures spinal interbody fusion cages made from polymers and metals, designed for non-sterile use, as well as bone-screw internal fixation systems for spinal stabilization. The company also produces external orthopaedic and spinal fixation systems, including single-use devices, for surgical and post-operative support.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company 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 Eminent Spine LLC manufacture?
Eminent Spine LLC specializes in spinal medical devices, including polymeric and metallic spinal interbody fusion cages (used for vertebral fusion), bone-screw internal spinal fixation systems (for stabilizing the spine), and external fixation systems (for orthopaedic and spinal support). These devices are designed for both surgical and post-operative applications, with some intended for single-use.
Where is Eminent Spine LLC based, and what does that mean for its regulatory oversight?
Eminent Spine LLC is based in the United States, which means its devices are subject to FDA regulatory requirements. Since all listed devices fall under FDA Class II classification, they undergo premarket notification (510(k)) review or other applicable pathways before being recorded in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list Eminent Spine LLC’s devices?
Eminent Spine LLC’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the U.S., ensuring traceability and compliance with FDA requirements for Class II devices.
How are Eminent Spine LLC’s devices classified under FDA regulations?
All of Eminent Spine LLC’s listed devices are classified as FDA Class II. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness, beyond general controls like good manufacturing practices.
What distinguishes Eminent Spine LLC’s external fixation systems from its internal spinal devices?
Eminent Spine LLC’s external fixation systems are designed for external skeletal support, often used pre- or post-operatively to stabilize bones or the spine without surgical implantation. In contrast, its internal spinal fixation systems (like bone-screw systems) are implanted during surgery to provide direct stabilization of the spine, while interbody fusion cages are placed between vertebrae to facilitate bone growth and fusion.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 022576742
Catalogue (899)
Page 18 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Peanut Plate | FPS10 | FDA UDI | Class II | Active |
| Copperhead | C5507 | FDA UDI | Class II | Active |
| Copperhead | C7007 | FDA UDI | Class II | Active |
| Copperhead | C6011 | FDA UDI | Class II | Active |
| Pre-Bent Rod | ICR13055 | FDA UDI | Class II | Active |
| Osteotomy Wedge | FOWR08 | FDA UDI | Class II | Active |
| Texas Sidewinder | T4008 | FDA UDI | Class II | Active |
| Lateral | ILC175522 | FDA UDI | Class II | Active |
| Osteotomy L Plate | FOLR27 | FDA UDI | Class II | Active |
| Poly-Axial Reduction | IHP7055 | FDA UDI | Class II | Active |
| Texas Python | P6016 | FDA UDI | Class II | Active |
| Texas Diamondback | DBCM5540 | FDA UDI | Class II | Active |
| Kingsnake | KS7112 | FDA UDI | Class II | Active |
| Lateral | ILC135018 | FDA UDI | Class II | Active |
| Texas Python | P5014 | FDA UDI | Class II | Active |
| Fanged Evans Plate | FEP1 | FDA UDI | Class II | Active |
| Texas Diamondback | DB4060 | FDA UDI | Class II | Active |
| Texas Python | PL4014 | FDA UDI | Class II | Active |
| Cottonmouth | A3116 | FDA UDI | Class II | Active |
| Kingsnake | KS7010 | FDA UDI | Class II | Active |
| Lateral | ILC115022 | FDA UDI | Class II | Active |
| Osteotomy L Plate | FOLR33 | FDA UDI | Class II | Active |
| Copperhead | C3006 | FDA UDI | Class II | Active |
| Foot Plate Screw | FPS2714 | FDA UDI | Class II | Active |
| Copperhead | C6012 | FDA UDI | Class II | Active |
| Cottonmouth | A1020 | FDA UDI | Class II | Active |
| Pre-Bent Rod | ICR11055 | FDA UDI | Class II | Active |
| Oblique | O3013 | FDA UDI | Class II | Active |
| Cottonmouth | A2018 | FDA UDI | Class II | Active |
| Metatarsal Plate | FMT30 | FDA UDI | Class II | Active |
| Texas Diamondback | DBCM5525 | FDA UDI | Class II | Active |
| Fanged Evans Plate | FEP3 | FDA UDI | Class II | Active |
| Poly-Axial Reduction | IHP5055 | FDA UDI | Class II | Active |
| Copperhead | C6009 | FDA UDI | Class II | Active |
| Eminent Spine Scoliosis Deformity Pedicle Screw System | K242069 | FDA 510(k) | Class II | Active |
| Eminent Spine 3D Cervical Interbody Fusion System | K212701 | FDA 510(k) | Class II | Active |
| Eminent Spine Buttress (fang) Plate System | K090415 | FDA 510(k) | Class II | Active |
| Cervical Stand-Alone System | K212853 | FDA 510(k) | Class II | Active |
| Diamond Rattlesnake System | K133194 | FDA 510(k) | Class II | Active |
| Eminent Spine Interbody Fusion System | K090064 | FDA 510(k) | Class II | Active |
| King Cobra Anterior Cervical Plate | K103068 | FDA 510(k) | Class II | Active |
| Cervical Plate System | K201979 | FDA 510(k) | Class II | Active |
| Standalone ALIF Interbody Fusion System | K221936 | FDA 510(k) | Class II | Active |
| Eminent Spine 3D Titanium Pedicle Screw System | K241663 | FDA 510(k) | Class II | Active |
| Eminent Spine 3D Lumbar Interbody Fusion Systems | K230219 | FDA 510(k) | Class II | Active |
| Eminent Spine Posterior SI System | K250894 | FDA 510(k) | Class II | Active |
| Eminent Foot Plate System | K143365 | FDA 510(k) | Class II | Active |
| Diamondback Spinal System | K100377 | FDA 510(k) | Class II | Active |
| Eminent Spine SI Screw System | K240505 | FDA 510(k) | Class II | Active |
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