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Medical Devices / Regulatory Affairs / Submissions and Approvals

Aurora Spine Receives FDA 510(k) Clearance for Zip Interspinous Fusion System

Dec. 5, 2013

Aurora Spine on Dec. 3 received 510(k) clearance from the FDA for its next-generation Zip Interspinous fusion spinal fixation device that fuses vertebrae to relieve back pain and other spinal maladies.

The device replaces the currently available pedicle screw systems. It contains articulating bone anchors, a one-step locking mechanism that cuts out the need for a set screw, and a space for biologic bone graft material.

These unique features lead to less blood loss and decreased surgery time, as well as quicker recovery, said Aurora spokesperson Justin Marcus.

Aurora intends to make the system available immediately in the U.S. via a network of more than 35 distributors. The device won EU CE Mark approval in June and is also available in Iceland, Norway and Liechtenstein. — Lena Freund

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