Eminent Spine received FDA 510(k) clearance of their 3D Titanium Anterior Lumbar Interbody Fusion (ALIF) Stand-Alone System in 2022. Since then, the company has marked a total of 40 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for ALIF. 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 to 35 millimeters and 5.0 to 5.5 in diameter.
The 3D ALIF comprises 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 feedback has been positive regarding the simplicity of the instrumentation and variety of footprints offered. No reports occurred 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 indicates that device 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 FDA-cleared).
Eminent Spine received FDA 510(k) clearance of their 3D Titanium Anterior Lumbar Interbody Fusion (ALIF) Stand-Alone System in 2022. Since then, the company has marked a total of 40 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for ALIF. The implants also come paired with screws that are self-tapping...
Eminent Spine received FDA 510(k) clearance of their 3D Titanium Anterior Lumbar Interbody Fusion (ALIF) Stand-Alone System in 2022. Since then, the company has marked a total of 40 3D Titanium ALIF Stand-Alone implants used in procedures in patients who were candidates for ALIF. 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 to 35 millimeters and 5.0 to 5.5 in diameter.
The 3D ALIF comprises 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 feedback has been positive regarding the simplicity of the instrumentation and variety of footprints offered. No reports occurred 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 indicates that device 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 FDA-cleared).
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