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 a line extension to the existing, approved Mini-Frag System, with additional screw and plate options, and indications. This additional clearance expands Tyber Medical products’ healing capabilities and adds to their restorative portfolio.
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions and fusions in the hand, wrist, foot and ankle. The Anatomical Plating System provides versatility, precision and efficiency in one system, and is offered in both titanium and stainless-steel. Tyber Medical’s Founder and CEO Jeff Tyber commented, “we expect this product to drive significant growth for our customers.”
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The line extension to the Mini-Frag System includes 1.3mm screws and plates, expanding the range of sizes in the Tyber Medical Mini-Frag System. “The clearance for the additional plates and screws offers surgeons the ability to treat a larger population, specific to smaller anatomy,” said Eric Dickson, Sr. Director of World-Wide Strategic Partnerships.
Tyber Medical LLC, is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-enhancing, regulatory-approved orthopedic implants for the spinal, extremity, and trauma markets. Tyber Medical provides customers with a quick and seamless path to market. Since it was founded in 2012, the company has released more than 50 spine, extremity, and trauma systems. Tyber Medical aims to develop and utilize differentiated technologies to make advanced orthopedic implants.
SOURCE : PRNewswire