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Medical Devices / Submissions and Approvals / Commercial Operations

FDA Gives 510(k) Nod to Titan Spine’s Endoskeleton TL Fusion System

July 16, 2014
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Spinal implant maker Titan Spine said Monday that its Endoskeleton TL, a spinal fusion system with a lateral approach, received FDA clearance for commercial release.

The Endoskeleton TL is the first lateral fusion device to feature surface technology designed to create an osteogenic response to the implant’s structure, according to the Mequon, Wisc., company. Its large windows and internal volumes allow for bone graft packing, clear CT and MRI imaging, preferred bone graft loading and the capability to pack additional bone graft material inside the device after implantation, the devicemaker added.

Titan Spine plan to initially roll out the device in select U.S. and European markets before launching it across those regions later this year, Andrew Shepherd, vice president of marketing, told Device Daily Bulletin. It received a CE Mark on July 2, he added.

The Endoskeleton TL is part of a full line of Endoskeleton devices that feature the company’s combination of roughened topographies at the macro, micro and cellular levels. — Kellen Owings

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