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Alphatec Holdings, Inc.
, 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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