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Nvision Biomedical Technologies Receives FDA Clearance for Pedicle Screw System

Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, has received clearance from the U.S. Food and Drug Administration (FDA) for its focus® Pedicle Screw System.

The Nvision focus Pedicle Screw System keeps patient safety in mind by concentrating on ease and flexibility of use by surgeons. The system offers both minimally invasive and open surgery options with standard double lead thread and midline cortical thread options.

The midline cortical thread has a fast-starting initial thread, which allows the surgeon to move faster in surgery and saves turns of the wrist. Additionally, the cortical option provides surgeons the flexibility to utilize a midline approach and not just a pedicle approach. For minimally invasive surgeries, there is an extended tulip design which provides a break-away tab that eliminates unwanted tower disconnects.
 
“At Nvision, our goal is to create products that address industry challenges and provide solutions for surgeons,” said Tom Zink, Nvision Senior Vice President of Product Development. “The focus Pedicle Screw System is a key product in that portfolio, offering design and features that address surgical needs.”

The focus Pedicle Screw System is Nvision’s latest product to receive FDA clearance. The company has developed and manufactured several products that received FDA clearance, including four interbody fusion systems – the nv line, one anterior cervical plate system – the tangis® line, and a buttress plate system – the boundary® line. The interbody devices have multiple footprints to adapt to the general shape of the vertebral endplates. Each set is available in a variety of heights to accommodate patient variability. Additionally, Nvision offers products with Structural Encoding®, the industry’s most innovative solution for medical device identification with permanent direct part marking, as well as a portfolio of human tissue allograft products including celera patches, fluids, and forma demineralized bone, and sport medicine grafts.