SIBN - SI-BONE iFuse Bedrock Granite for pelvic fixation gets FDA nod

SI-BONE (NASDAQ:SIBN) said its received the U.S. Food and Drug Administration's (FDA) 510(k) premarket clearance for its iFuse Bedrock Granite Implant System for use in pelvic fixation. The company said the Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. SI-BONE (SIBN) noted that the clearance follows the FDA's breakthrough device  designation for the system, and most recently, a proposal by the Centers for Medicare and Medicaid Services for a New Technology Add-on Payment.

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SI-BONE iFuse Bedrock Granite for pelvic fixation gets FDA nod