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 IDK150875
510k NumberK150875
Device Name:IFuse Implant System
ClassificationSacroiliac Joint Fixation
Applicant SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose,  CA  95128
ContactRoxanne Dubois
CorrespondentRoxanne Dubois
SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose,  CA  95128
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-01
Decision Date2015-07-22
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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