IFuse 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 Implant System®.

Pre-market Notification Details

Device IDK182983
510k NumberK182983
Device Name:IFuse Implant System®
ClassificationSacroiliac Joint Fixation
Applicant SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
ContactRoxanne Dubois
CorrespondentRoxanne J. Dubois
SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-29
Decision Date2018-11-27
Summary:summary

Trademark Results [IFuse Implant System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IFUSE IMPLANT SYSTEM
IFUSE IMPLANT SYSTEM
77799568 3881099 Live/Registered
SI-BONE, Inc.
2009-08-07

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