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K2M Surpasses 100th Product Milestone with FDA Clearance and Launch of OZARK Cervical Plate Systems
Jun. 07, 2018 08:42AM PST
Medical Device InvestingK2M Group (NASDAQ:KTWO) a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today surpassed its 100th product milestone with the announcement of U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its OZARK™ Cervical Plate Systems—designed for anterior screw fixation to the cervical spine (C2-T1) …
K2M Group (NASDAQ:KTWO) a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today surpassed its 100th product milestone with the announcement of U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its OZARK™ Cervical Plate Systems—designed for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. This milestone highlights the depth and breadth of K2M’s 3D spinal balance portfolio, its cervical solutions offering, and crystalizes the Company’s commitment to improving surgical outcomes for people living with spinal disease.
As quoted in the press release:
“K2M is excited to celebrate our 100th product milestone following regulatory clearance for the OZARK Cervical Plate Systems, the latest in our growing portfolio of cervical solutions designed to facilitate 3D spinal balance in patients,” said K2M Chief Medical Officer and Co-founder John P. Kostuik, MD. “At K2M, excellence in innovation is at the heart of all that we do. Since our founding we’ve focused on developing groundbreaking solutions for patients with spinal disease and remain dedicated to furthering this legacy.”
The OZARK Cervical Plate Systems are available in two designs, OZARK Guide and OZARK View, both featuring an advanced per-level, integrated locking cover that provides surgeons with clear visual and tactile confirmation of the final lock position. They both include a full range of plate and screw sizes and instrumentation for creating constrained, semi-constrained or hybrid screw constructs. The systems are compatible with K2M’s CASCADIA™ Cervical 3D Interbody Systems featuring Lamellar 3D Titanium Technology™, which uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques.
