K-number	K233508
Device name	iFuse Bedrock Granite® Implant System
Applicant	SI-BONE, Inc.
Product code	OUR
Device class	Class II
Decision date	Jan 26, 2024
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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iFuse Bedrock Granite® Implant System

Everything you need for a 510(k) submission. Nothing you don't.