Web1 jun. 2024 · iFuse Bedrock Granite implant system is designed to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. SI … Web22 feb. 2024 · 1. iFuse Bedrock Granite was awarded Breakthrough Device Designation (BDD) by the FDA: Adult spinal deformity continues to present itself as a complex clinical …

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

Web2 okt. 2024 · This guidance was amended in 2024 to include the iFuse-3D implant, which evidence suggests may be clinically equivalent to the original iFuse implant. Cost modelling indicates that iFuse is cost incurring until year 9, when using iFuse with the original implants instead of non-surgical management will save the NHS around £230 per person. Web27 dec. 2024 · SI-BONE Inc. (SIBN) announced an additional FDA clearance for iFuse Bedrock Granite. New cleared indications include use with a wide variety of … boston logan cancelled flights

SI-BONE, Inc. Announces FDA Clearance for Expanded Rod …

Web19 apr. 2024 · The Granite implant is intended to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. The Granite implant was … Web15 apr. 2024 · The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and … WebThe SI-BONE iFuse-TORQ Implant System has the same intended use, similar indications for use and technological characteristics as the FDA cleared Medacta International M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (most recently cleared in K193083 and K171595). The iFuse- boston logan flight monitor