Tyber Medical LLC secures FDA 510(k) approval for its Proximal Tibia Plating System, catering to complete and partial articular fractures. The system offers customizable solutions for tibia, fibula, and femur injuries, emphasizing anatomical plating and variable screw options. Chief Technology Officer David Hannah highlights its versatility, while Director of Regulatory Affairs Lisa Boyle underscores Tyber Medical’s dedication to innovative orthopedic solutions.
Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia Plating System. The Tyber Medical System consists of two indication categories: Complete Articular and Partial Articular Fractures. Both designs stabilize bone fragments to facilitate highly focused and efficient healing of a wide array of injuries to the tibia, fibula, and femur. “This innovative addition to the Tyber Medical portfolio aligns to meet the needs of our customers by offering multiple solutions to challenging anatomy,” commented David Hannah, Chief Technology Officer at Tyber Medical. Mr. Hannah added. “This comprehensive system offers anatomic plating to support a wide range of trauma needs.”
The Tyber Medical Proximal Tibial Plating System is engineered to accommodate surgeon preferences, increase procedural efficiency, and enhance plate fit and screw placement. The Proximal Tibia system is anatomically designed to address a variety of indications and includes variable angle locking and non-locking screws. Lisa Boyle, Director of Regulatory Affairs commented “With the clearance of the Proximal Tibial Plating System and its sub-categories, Tyber Medical remains unwavering in our commitment to providing cutting edge orthopedic solutions.”
Source: Bio Space
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