IFuse Bedrock Granite™ Implant System

Sacroiliac Joint Fixation

SI-BONE, Inc.

The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Bedrock Granite™ Implant System.

Pre-market Notification Details

Device IDK220195
510k NumberK220195
Device Name:IFuse Bedrock Granite™ Implant System
ClassificationSacroiliac Joint Fixation
Applicant SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
ContactMeirav Harsat
CorrespondentMeirav Harsat
SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
Product CodeOUR  
Subsequent Product CodeNKB
Subsequent Product CodeOLO
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-24
Decision Date2022-05-26

NIH GUDID Devices

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Trademark Results [IFuse Bedrock Granite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IFUSE BEDROCK GRANITE
IFUSE BEDROCK GRANITE
88901123 not registered Live/Pending
SI-BONE, Inc.
2020-05-05

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