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January 3, 2013
07:41 EDTATECAlphatec receives FDA 501k clearance for two new products
Alphatec announced that it has recently received 510k market clearance from the FDA for two new products in the company's new product pipeline: An anchored, anterior cervical interbody device, called Pegasus and a new MIS system, called ILLICO FS Facet Fixation System, which enables spine surgeons to immobilize and stabilize spinal segments without the need for pedicle screw and rod constructs. Additionally, the company said that it has 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.
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