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Medical Devices / Submissions and Approvals

FDA Clears Camber Spine 3D-Printed Interbody Fusion Implant

Dec. 12, 2017

The FDA issued 510(k) clearance to Camber Spine for its SPIRA –C Open Matrix Cervical Interbody device.

The 3D-printed implant features a roughed titanium surface designed to promote bone cell proliferation, and a pore size optimized for bone ingrowth.

It is indicated for use at one or two contiguous intervertebral levels in patients who have received at least six week of nonsurgical treatment for degenerative disk diseases. This is the second clearance the firm has obtained over the last four months for an implant in its SPIRA family.

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