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K2M announces FDA 510(k) clearance, launch of cervical plate systems
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K2M Group Holdings Inc. received FDA 510(k) clearance for and commercially released its OZARK cervical plate systems, designed for use in patients with degenerative disease, deformity, tumor, or trauma as an anterior screw fixation to the cervical spine (C2-T1).
“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 3-D spinal balance in patients,” said John P. Kostuik, MD, K2M chief medical officer and co-founder.
According to the release, the OZARK cervical plate systems features a locking cover that offers clear visual and tactile view of the final lock position, a variety of plate and screw sizes and instrumentation for creating constrained, semi-constrained or hybrid screw constructs. Two designs, OZARK Guide and OZARK View, are available.
The OZARK cervical plate system is also compatible with other K2M products like CASCADIA cervical 3-D interbody systems, which uses an advanced 3-D printing method to create structures, and Balance ACS, a comprehensive platform applying 3-D solutions to address each anatomical vertebral segment with a 360° approach to the axial, coronal, and sagittal planes.
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