SurGenTec’s OsteoFlo HydroFiber FDA cleared for standalone use

SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a stand-alone equivalent to autografts in spine surgeries.

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OsteoFlo HydroFiber uses web interface technology to prevent graft migration and ensure cohesiveness and flowability, according to a news release. It is designed for use in interbody fusion cages, disc spaces, and posterolateral fusions. The product can also be used with SurGenTec’s Graftgun for backfilling interbody cages. 

“OsteoFlo HydroFiber provides a novel, customizable solution for surgeons, tailored to both anatomy and procedure type,” CEO and founder of SurGenTec, Travis Greenhalgh, said in the release. “Physicians are familiar with the handling characteristics of fiber-based allograft products, and we are proud to introduce a synthetic option designed to accelerate healing without the risk of human allograft tissue.”

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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