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Alphatec gains 510(k) clearance for cervical interbody device, fixation system
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Alphatec Holdings Inc. was granted 510(k) market clearance from the FDA for the Pegasus and the Illico FS Facet Fixation System, according to a company news release.
The Pegasus is an anchored, anterior cervical interbody device which offers single-step deployment of the anchoring blades without impaction. The Illico FS Facet Fixation System is a new minimally invasive surgery system which enables spine surgeons to immobilize and stabilize spinal segments without pedicle screw and rod constructs.
Alphatec has also received Shonin approval in Japan from the Pharmaceuticals and Medical Devices Agency to market and sell three lines of the company’s novel PEEK Spinal Spacers, including the Novel SD, the Novel LCC and the Novel TL, which are used in posterior spine fusion procedures.
“Our initiatives to strengthen the top-line growth of the company through robust internal product development, acquisitions and license arrangements, and continued global expansion are gaining momentum,” Les Cross, chairman and chief executive officer of Alphatec Spine, stated in the release.