Oxiplex is designed to be used during lumbar spine surgery. It’s a viscoelastic gel and has been sold in Europe since 2001. FzioMed has been striving since then to get U.S. market approval.
During a special Medical Device Dispute Resolution Panel, the FDA approved the company’s petition for an independent review after an earlier agency denial of the gel.
More Articles on Devices:
Zimmer Spine Launches Viewline MIS Instruments
Roberto Quarta to Serve as Smith & Nephew’s New Chairman
AxoGen Profits Up 60% in Q3 to $2.31M
