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Medical Devices / Submissions and Approvals

Nextremity Gains 510(k) Clearance for Foot Plating System

April 5, 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.

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