SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

SI-BONE was granted FDA 510(k) clearance to market the iFuse Bedrock Granite Implant System. The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.

This clearance follows an earlier designation by FDA of Granite as a Breakthrough Device, and most recently, a proposal by the...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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