www.fdanews.com/articles/190822-nextremity-gains-510k-clearance-for-foot-plating-system
Nextremity Gains 510(k) Clearance for Foot Plating System
April 4, 2019
Nextremity received the FDA’s clearance for its Stratum foot plating system, a plate and screw system used to treat issues with bones in the foot.
The device is indicated for fixating fractures, osteotomies, malunions, non-unions and fusions of small bones and segments—particularly in bones that are weaker than normal.
The system includes a plate and non-locking, locking and/or multi-directional locking screws, as well as sterile accessory instruments and drill bits for bone insertion and implant site preparation.