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SI-BONE获得510（k）批准和FDA突破性器械指定

2024-08-20 22:24

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SI-BONE (NASDAQ:SIBN) on Tuesday announced FDA 510(k) clearance of the iFuse TORQ TNT Implant System.
TNT was awarded Breakthrough Device Designation by the FDA.
In designating TNT as a Breakthrough Device, the FDA determined that it has the potential to provide more effective treatment of pelvic fragility fractures than the current standard of care, cannulated screws.
Press release.

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