SI-Bone's pelvic fixation device gets FDA nod

Spinal Tech

SI-Bone's iFuse Bedrock Granite implant system for sacroiliac fusion and sacropelvic fixation received FDA clearance.

The device had earlier FDA designation as a breakthrough device and received a new technology add-on payment from CMS, according to a May 31 news release. It is designed for sacropelvic anatomy.

The iFuse Bedrock Granite is also expected to reduce the need for reoperations in spinal deformity cases, the release said.

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