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Eminent Spine’s 3D Titanium Anterior Lumbar Stand-Alone System Usage Report and Clinical Study

January 5, 2024 By SPINEMarketGroup

Plano, TX, January 04, 2024 –(PR.com)– Eminent Spine received 510(k) approval of their 3D Titanium Anterior Lumbar Interbody Fusion Stand-Alone System in October of 2022. Since then, Eminent Spine has had a total of 40 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for an Anterior Lumbar Interbody Fusion. The implants also come paired with screws that are self-tapping and self-drilling. Of the 120 screws used, all 120 were variable and ranged from 20-35 millimeters and 5.0-5.5 in diameter.

The 3D ALIF is comprised of various sizes and configurations to accommodate individual patient anatomy. The implant was designed with the following: a tapered nose and rounded edges which allows for ease of insertion, aggressive teeth to resist migration, lordosis for ease of insertion, self-distraction, and aggressive teeth for implant fixation. The implant profiles include heights ranging from 10-20mm, 5 different width x depth options, and lordosis of 12 degrees (custom lordosis of 0, 6, 18, 24, and 30 degrees are available upon request). The locking tab shows visible security of self-tapping, self-drilling screws. Surgeon’s feedback has been positive regarding the simplicity of the instrumentation and variety of footprints offered. There has been no reports of screw back-out, screw breakage, cage migration, cage fracture, or malfunction of the locking mechanism. This study of the Eminent Spine Cervical Stand-Alone has shown that the Eminent Spine 3D Titanium ALIF Stand-Alone is a device that can be safely implanted.

Eminent Spine’s 3D Titanium ALIF Stand-Alone System includes non-sterile implants with a wide range of implant profiles with both fixed and variable screw options. The 3D Titanium ALIF Stand-Alone is accompanied by Eminent Spine’s 3D Titanium Lumbar Interbody Fusion Systems PLIF and TLIF (also received FDA 510(K) clearance in May of 2023). Eminent Spine also has a completed ALIF prep set available per request.

“Keep it simple.”

Contact

Eminent Spine
Sydney Ewing
972-499-3593
www.eminentspine.com

Filed Under: NEWS Tagged With: 2024

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