FDA Grants Eden Spine 510(K) Clearance for Its Thoraco Lumbar Spine Locking Plate - SPHYNX™

Thursday, August 30, 2018 Drug News
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Eden Spine (http://www.EdenSpine.com), an R&D driven medical technology company, announced today that the SPHYNX™ plating system gained FDA Clearance.

GENEVA, Switzerland, Aug. 30, 2018 /PRNewswire-PRWeb/ -- The SPHYNX™ is the ideal complement to Eden

Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA™ which provides multiple angulation options by simple endplates rotation. The GIZA™ is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.

Made of titanium, the low profile SPHYNX™ is to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.

"The SPHYNX™ is the latest innovation coming from our R&D department in Geneva, Switzerland," says Ben Mokhtar, President of Eden Spine Europe, SA. "Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal we have developed a cutting edge integrated locking system, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient's anatomy." The SPHYNX™ was granted CE Mark approval in 2016.

About Eden Spine Europe SA: Eden Spine is a privately held, technology driven spinal organization based in Switzerland since 2005. The company distributes a range of innovative spinal technologies in the United States and abroad. Eden Spine patented portfolio is composed of a mix of fusion and non-fusion technologies.

For distribution opportunities, please contact us at Customer.service(at)edenspine(dot)com or visit http://www.edenspine.com

 

SOURCE Eden Spine



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