Healthcare Industry News: cervical spine
News Release - February 7, 2008
Life Spine Announces FDA Approval of Kinetic(R)-SLInternally dynamized cervical plate system now features zero step lockup
HOFFMAN ESTATES, Ill., Feb. 7 (HSMN NewsFeed) -- Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to Kinetic®-SL, a new internally dynamized anterior cervical plating system.
Michael S. Butler, Life Spine's president, CEO and founder, said Kinetic's flexibility of design will allow surgeons another alternative when performing cervical spine surgery with a dynamic cervical plate system. "Kinetic-SL represents a new spin on our highly successful Kinetic product," Butler said. "Surgeon reaction to our zero-step locking mechanism developed with our Neo®-SL static plate has been fantastic, and we wanted to expand our offering to add these unique features to our internally dynamized cervical plate offering. We now have an entire family of cervical options to address a wide variety of patient and surgeon needs, including two static anterior cervical plating systems and now two unique internally dynamized cervical plate offerings."
This unique plate, with an exceptionally thin profile as well as a narrow plate width (16mm), was created from the clinical need to address small stature patients. Like the original Kinetic, Kinetic-SL features 0-2mm of fully adjustable internal dynamization per level and an ultra slim pre- lordosed profile. Plate sizes range from 21mm to 111mm, in levels one to five. The Kinetic design allows for generous screw angulation, as well as a large graft window, a feature which competitive products do not have. Like the company's Neo-SL plate, an integrated lock allows bone screws to be securely fixated without any additional locking components. The self- retaining screw capture mechanism prevents screw backout, while still allowing screw angulation.
About Life Spine
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 has been on a rapid pace in achieving regulatory approvals, receiving several significant 510(k) approvals from the FDA for new products in the last year. Life Spine, which is privately held, is based in Hoffman Estates, Illinois, and additional information about the company can be found at: http://www.lifespine.com.
Source: Life Spine
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