Healthcare Industry News: cervical spine
News Release - June 25, 2007
Life Spine Announces FDA Approval of Neo(R)-SLNew anterior cervical plating system features zero step locking
HOFFMAN ESTATES, Ill., June 25 (HSMN NewsFeed) -- Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to NeoŽ-SL, a new static anterior cervical plating system with an integrated lock that allows bone screws to be securely fixated without any additional locking components. The self-retaining screw capture mechanism prevents screw rotation and backout, while still allowing screw angulation. In addition to the zero step locking feature, NeoŽ-SL boasts the following features:
-- Ultra slim 2mm profile
-- Narrow plate width (16mm)
-- Newly designed fast turning (FT) bone screws
-- Large graft window, similar to the original NeoŽ plate, providing increased intra-operative and post-operative views of the graft site
-- Self-drilling, self-tapping, fixed and variable angle screws
-- Pre-lordosed plates in levels 1-5, with sizes from 20mm to 111mm
Michael S. Butler, Life Spine's president, CEO and founder, said NeoŽ-SL's flexibility of design will save surgeons a step or two when performing cervical spine surgery. "This is a time saving new product, which eliminates the need to employ any additional steps in order to prevent bone screw rotation or backout," Butler said. "The NeoŽ-SL is another product that is indicative of our commitment to develop time saving products that result in the best clinical outcomes for our surgeons' patients."
Life Spine has been on a rapid pace in achieving regulatory approvals, receiving nine separate 510(k) approvals from the FDA for new products in the last eleven months.
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Hoffman Estates, Illinois. For more information, please visit http://www.lifespine.com .
Source: Life Spine
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