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Medical Devices / Submissions and Approvals

K2M Group’s Cervical Plate System Receives FDA Clearance

June 11, 2018

The FDA granted 510(k) clearance to K2M Group’s Ozark cervical plate systems, designed for anterior screw fixation to the cervical spine in patients with deformity, tumor, trauma or degenerative disease.

The psystems are available in two designs — the Ozark Guide and Ozark View — and both feature a locking cover that gives surgeons a clear view of the final lock position.

The devices offer a full range of plate and screw sizes and instrumentation for constrained, semi-constrained or hybrid screw constructs, and are compatible with K2M’s Cascadia 3D interbody systems.

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