SI-Restore® Sacroiliac Joint Fixation System

Sacroiliac Joint Fixation

Biofusion Medical

The following data is part of a premarket notification filed by Biofusion Medical with the FDA for Si-restore® Sacroiliac Joint Fixation System.

Pre-market Notification Details

Device IDK182919
510k NumberK182919
Device Name:SI-Restore® Sacroiliac Joint Fixation System
ClassificationSacroiliac Joint Fixation
Applicant Biofusion Medical 2503 Cedarview Drive Austin,  TX  78704
ContactRylan Reed
CorrespondentDaniel Lanois
SurgOp Support 7512 Lancaster Gate Frisco,  TX  75035
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-19
Decision Date2019-01-25
Summary:summary

Trademark Results [SI-Restore]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SI-RESTORE
SI-RESTORE
87849969 5747103 Live/Registered
Bio Fusion Medical
2018-03-26
SI-RESTORE
SI-RESTORE
87849933 5747100 Live/Registered
Bio Fusion Medical
2018-03-26
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