FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Expands Clearance for Spineology’s Expandable Interbody Fusion System

March 14, 2017

Minnesota–based Spineology received expanded FDA clearance for the Elite expandable interbody fusion system, to include a 10m, version of the device and an indication for use with allograft bone.

The device implant is inserted into the disc space and is expanded once in position to restore anatomic disc height, provide column support, and facilitate indirect decompression.

The device is designed with titanium alloy and has a large graft window to enable bone through-growth and maximize fusion. — Cynthia Jessup