FDA 510(k), K220195, iFuse Bedrock Granite™ Implant System

510(K) Number: K220195
Device Name: iFuse Bedrock Granite™ Implant System
Manufacturer: SI-BONE, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 01/24/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Orthopedic

932 pages (1,819 of 2,751 original pages are fully redacted)