Medyssey Spine Receives FDA 510(k) Clearance For Zenius(TM) Thoracolumbar Spinal System In Titanium Alloy (Ti6AL-4V ELI)

Main Category: Bones / Orthopedics
Also Included In: Neurology / Neuroscience;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 26 Aug 2010 - 3:00 PDT

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South Korea-based Medyssey Co., Ltd. announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4.

The Zenius(TM) System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies. Zenius(TM) utilizes a Dove Tail Joint(TM) Set Screw with patent-pending reverse trapezoid thread design and linear slot to dramatically increase holding forces over a traditional (non-slotted) set screw.

"The clearance of the Zenius(TM) Spinal System rounds out Medyssey Spine's spinal instrumentation portfolio of Thoracolumbar PSF solutions in 5.5, 6.0 and 6.35 mm Rod Constructs through the Zenius(TM) and Novel systems," said Joseph Jin, vice president, Medyssey Spine. He added, "Medyssey is now investing into building out the orthobiologics and interbody platforms to support our core fusion, dynamic stabilization, and motion preservation systems."

Source: Medyssey Co., Ltd

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