K2M Gains FDA Clearance, CE Mark Approval for CAYMAN United Plate

By Julie A. Vetalice

K2M received FDA 510(k) clearance and CE Mark approval for the CAYMAN® United Plate, and announced completion of first surgical cases.

CAYMAN United is designed for rigid fixation to the CASCADIA™ Lateral 3D Interbody system, which features the company's Lamellar 3D Titanium Technology™.

The system's single level, 1- and 2- hole plate configurations match all CASCADIA height and lordosis options, supporting the ability to customize the construct using a lateral approach.

Source: K2M

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, CE Mark, Regulatory