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Medical Devices / Submissions and Approvals

FDA Grants 510(k) Clearance for Zavation’s Lumbar Spine Implants

June 6, 2019
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The FDA has given Zavation the go-ahead to market its Ti3Z Interbody System, a system used as an intervertebral body fusion device for the lower back.

The lumbar interbody implants are used in the lumbar spine, from L2 to S1, for treating degenerative disc disease with up to Grade I spondylolisthesis.

The system offers multiple heights, widths and lengths, in addition to parallel and angled implants to adapt to differing patient anatomies. The different configurations also enable physicians to use multiple surgical approaches.

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