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Vertera Spine receives FDA 510(k) clearance for PEEK lumbar interbody fusion device

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Vertera Spine announced FDA 510(k) clearance of its Coalesce lumbar interbody fusion device to be used in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures, according to a company press release.

According to the release, the lumbar interbody fusion device features a novel, proprietary porous polyetheretherketone (PEEK) material. The device reportedly combines the osseointegration capabilities of porous metal implants with the implant imaging and mechanical properties of traditional PEEK implants.

“Based on the initial success with the Cohere Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications,” said Chris Lee, Vertera Spine chief executive officer, said in the release. “We are pleased to have received FDA clearance for Coalesce and look forward to further serving surgeons’ clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging.”

Reference:

www.verteraspine.com