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K2M receives FDA clearance for the PYRENEES Mono Cervical Plate System

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K2M Group Holdings Inc. recently announced it received 510(k) clearance from the FDA to market the PYRENEES Mono Cervical Plate System. In addition, K2M also received a CE Mark for the system, which allows the company to expand the global availability of the product.

The system features a slim-profile design that allows for a single point of fixation per level. The posterior profile of the plate is designed to reduce plate migration in-situ during screw insertion. Additionally, the system includes one- and two-level plates, according to a company press release.

The plates in the system have no bend zones and are designed with lordotic curvature to minimize intraoperative contouring.

This is the third system to be offered in the PYRENEES family of cervical plates, which also includes the PYRENEES Constrained Cervical Plate System and the PYRENEES Translational Cervical Plate System.

Reference: www.k2m.com