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LDR receives 510(k) clearance of ROI-A ALIF cage

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LDR announced that it has received 510(k) clearance by the FDA to market its ROI-A Oblique ALIF cage. According to a company press release, the Oblique system uses LDR’s VerteBRIDGE plating technology and a specially designed cage for simple insertion and stable fixation.

“We are very excited to strengthen our worldwide leadership in stand-alone device innovation by introducing the first oblique ALIF stand-alone cage in the U.S. market,” Christopher Lavigne, president and chief executive officer of LDR, stated in the release.

The oblique cage and self-guided, curved VerteBRIDGE plating are delivered into the plane of the disc through a direct anterolateral approach. According to the release, this creates less exposure than insertion of a traditional ALIF cage or other contemporary stand-alone systems containing screws that must be inserted at divergent angles. The oblique cage also contains specially designed instrumentation, including an inserter that protects anatomical structures while implanting the cage and plating.