Medtronic (NYSE:MDT) said it gained 510(k) clearance for 1 spinal repair device and began the commercial rollout of another.
The global medical device giant said that the FDA cleared its Zevo anterior cervical plate system, a spinal fusion device designed to address damage stemming from cervical degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis and/or failed previous spinal fusions.
Zevo builds on previous iterations by having shorter plating options combined with hyper-screw angulations, so a surgeon can choose the smallest possible plate a patient needs and secure the plate as far as possible from the adjacent disc, Medtronic said.
Separately, Medtronic said it began rolling out its Divergence stand-alone interbody cage, a prosthesis used in spinal fusion procedures to help keep proper height and decompression of the spine. Among its features: An all-in-1 fusion device with internal screw fixation, with other improvements designed to help reduce retraction and incision.
Doug King, president of Medtronic’s spinal business, said in prepared remarks that the respective devices reflect "Medtronic’s commitment to responding to surgeon needs, and innovating in ways that improve patient treatment and care."
Medtronic’s spinal business is based in Memphis.