Alphatec's Spine Unit Receives FDA 510(k) Clearance for Two New Products
Alphatec Holdings, Inc. (Nasdaq: ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today provided an update related to its product commercialization efforts.
The Company announced that it has recently received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for two new products in the Company's new product pipeline:
* An anchored, anterior cervical interbody device, called Pegasus™, which offers single-step deployment of the anchoring blades without the need for impaction; 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, which are used in posterior spine fusion procedures. PEEK, or polyetheretherketone, is a radiolucent material containing radiographic markers, which enhance interbody visualization and alignment during the fusion process.
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