ChoiceSpine™ Granted FDA Clearance for Revolutionary Cervical Spine Interbody Fusion Device
KNOXVILLE, TN (PRWEB) October 25, 2017 -- ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, today announced the U.S. Food and Drug Administration (FDA) clearance (510k) of the revolutionary Blackhawk integrated anterior cervical fusion device featuring self-locking anchors and a large center graft chamber.
“The Blackhawk clearance expands the ChoiceSpine cervical fusion product portfolio to make it the one resource for all cervical spinal fusion procedures with the most comprehensive product portfolio in the industry,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “Our expanded portfolio is now poised to meet the varying surgical needs of spine surgeons in demanding anterior and posterior cervical spinal fusion procedures.”
Over 250,000 cervical spinal fusion procedures are performed each year in the United States.1 In anterior fusion procedures, spine surgeons want to use a device that is low profile, has a large graft area and is fast to insert. “The Blackhawk device meets these surgical needs as it offers sleek instruments for quick implant insertion into the interbody space. Blackhawk is then secured and locked in a single step. The single-step locking combines anchor insertion through the implant with a self-locking mechanism for ease and speed.” explains KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine. “The Blackhawk device is offered in a wide variety of heights, footprints and lordotic angles to accommodate a variety of anatomical conditions.”
Stephen Ainsworth, PhD, Vice President of Research & Development, ChoiceSpine, states, “The Blackhawk revolutionary design offers an anterior cervical device with a large center graft chamber and integrated, self-locking anchors that ensure graft compression while leaving no profile outside the confines of the interbody space potentially reducing patient discomfort and post-op complications.”
The Blackhawk integrated, anterior cervical interbody device was designed to stabilize and fuse the cervical spine with integrated, self-locking anchors. Blackhawk is available in small and large surface footprints that range in height from 5 to 10 mm with profiles of parallel, lordotic or convex. The integrated, self-locking anchors have a 15° medial convergence for secure implantation.
About ChoiceSpine
ChoiceSpine™ is a privately held spinal implant company located in Knoxville, TN. Founded in 2006, Choice offers an extensive array of innovative, surgeon focused systems designed with the best clinical outcomes in mind. In addition, ChoiceSpine offers a full regenerative and osteobiologics portfolio including synthetics, DBM’s, structural allograft, and amnion allografts. With cutting edge technology in their Veo™ VLIF lateral fusion line to the incorporation of Hydroxyapetite (HA) in their PEEK® interbody systems, ChoiceSpine is committed to always staying ahead of market trends and to provide surgeons with dynamic solutions for their patients.
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1. Orthopedic Network News, Volume 27, Number 4, October 2016
KC Gilbert, ChoiceSpine, http://choicespine.com, +1 5405293306, [email protected]
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