Eminent Spine Gains FDA 510(k) for Cervical Standalone System

By Julie A. Vetalice

Eminent Spine Gains FDA 510(k) for Cervical Standalone System

Eminent Spine received FDA 510(k) clearance to market a Cervical Stand-Alone System.

The implant was designed with a tapered nose which allows for ease of insertion, lordosis for ease of insertion, self-distraction and aggressive teeth for implant fixation. Micro-teeth on the top faces of the implant prevent micro-migration and micro-motion. The locking tab shows visible security of self-tapping, self-drilling screws. There is one universal driver for screws and locking tab for ease in the O.R. Surgeon’s feedback has been positive regarding the simplicity of the instrumentation and numerous footprints offered.

Eminent Spine's Cervical Stand-Alone System includes non-sterile implants with a wide range of implant profiles with both fixed and variable screw options. The Cervical Stand-Alone System is accompanied by Eminent Spine’s extensive cervical IBFD cages, which are available in PEEK, Machined Titanium and 3D Printed Titanium (pending 510(k) clearance) and also the newly released Anterior Cervical Plate System.

Source: Eminent Spine

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory