FDA OK's Independent Review of Oxiplex Gel for Lumbar Spine Surgery

FzioMed will have an independent review of its Oxiplex Gel premarket approval application, as per approval from the commissioner of the U.S. Food and Drug Administration. 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.

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