Genesys Spine Sacroiliac Joint Fusion System

Sacroiliac Joint Fixation

Genesys Spine

The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Sacroiliac Joint Fusion System.

Pre-market Notification Details

Device IDK191748
510k NumberK191748
Device Name:Genesys Spine Sacroiliac Joint Fusion System
ClassificationSacroiliac Joint Fixation
Applicant Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin,  TX  78746
ContactWilliam W. Sowers
CorrespondentWilliam W. Sowers
Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin,  TX  78746
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-09-26
Summary:summary

NIH GUDID Devices

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