K2M received FDA 510(k) clearance to market the PYRENEES Mono Cervical Plate System.
Here are five key notes:
1. The system is the company's the third offering in the PYRENEES product family.
2. The PYRENEES Mono Cervical Plate System includes one-and two-level plates.
3. It features a slim-profile design that allows for a single point of fixation per level that aims to improve visualization in-situ.
4. The posterior profile of the plate is designed to reduce plate migration in-situ during screw insertion.
5. K2M has also received a CE Mark for the system.