FDAnews Device Daily Bulletin

FDA Clears Vertera’s New Interbody Fusion Device

July 31, 2017

Vertera Spine’s Coalesce device, used for lumbar interbody fusion, received 510(k) clearance from the FDA.

Intended for use in lumbar interbody fusion procedures, the device combines the benefits of porous metal with the mechanical and imaging properties of traditional implants. Unlike 3D-printed implants, the device behaves similarly to bone under compression.

The company plans to launch the device for use in lumbar interbody fusion procedures later this year.

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