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Aurora Spine Reports FDA Clearance for AERO Facet Fusion System
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Aurora Spine Reports FDA Clearance for AERO Facet Fusion System
Mar 25, 2025 5:14 AM

07:45 AM EDT, 03/25/2025 (MT Newswires) -- Aurora Spine ( ASAPF ) on Tuesday said the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's AERO Facet Fusion System.

AERO provides a minimally invasive solution for patients suffering from facet joint-related pain or instability. Cleared for use from spinal levels C2 to S1 (inclusive), it is meant for patients experiencing mechanical back pain, minor instability, or degenerative joint disease who have not responded to conservative therapies.

Initial surgeries utilizing the AERO system are expected to begin in the third quarter of this year. Several spine surgeons have already been selected to participate in an initial clinical study to validate the device's clinical outcomes and long-term benefits, Aurora said.

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