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Eisertech receives 510k clearance for cervical and lumbar cage implants

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Eisertech LLC received 510k clearance from the FDA for it new cervical and lumbar cage implants. The new implants, which are made with Zeniva polyetheretherketone (PEEK) rods from Solvay Specialty Products USA LLC, were cleared based in part of the master access file for Zeniva PEEK.

According to a company press release, since the cage systems are hollow, they fuse the adjacent bony surfaces of the vertebrae as the bone grows through the device. The rods show no evidence of cytotoxicity, sensitization, irritation or acute systemic toxicity, and have high strength and stiffness, as well as radiolucent properties, permitting X-ray procedures.

“Zeniva PEEK delivers the high performance properties that are necessary for a high-precision implant used in cervical spine fusion surgery,” Lukas Eisermann, president of Eisertech, stated in the release.