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SI-Bone's iFuse Implant System Receives 510(K) Clearance, Breakthrough Device Designation From FDA
2024-08-20 21:27
09:27 AM EDT, 08/20/2024 (MT Newswires) -- SI-Bone (SIBN) said Tuesday that it has received 510(k) clearance and Breakthrough Device Designation from the US Food and Drug Administration for its iFuse TORQ TNT Implant System.
The 501(k) clearance designates new devices that the regulator determines are substantially equivalent to a device that is already on the market. The FDA's Breakthrough Device Designation is intended to provide timely access to medical devices by accelerating development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
Shares of SI-Bone were up 1.8% in recent premarket activity.
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