FIREBIRD SI Fusion System

Sacroiliac Joint Fixation

Orthofix Inc.

The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Firebird Si Fusion System.

Pre-market Notification Details

Device IDK210667
510k NumberK210667
Device Name:FIREBIRD SI Fusion System
ClassificationSacroiliac Joint Fixation
Applicant Orthofix Inc. 3451 Plano Parkway Lewisville,  TX  75056
ContactJacki Koch
CorrespondentJacki Koch
Orthofix Inc. 3451 Plano Parkway Lewisville,  TX  75056
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-05
Decision Date2021-03-25

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