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

Device IdentifiersubmissionNumberSupplement
M719GSI210030 K191748 000
M719GSISO095400 K191748 000
M719GSISDWB095700 K191748 000
M719GSISD095300 K191748 000
M719GSI313220 K191748 000
M719GSI261STS0 K191748 000
M719GSI2580 K191748 000
M719GSI256NBS0 K191748 000
M719GSI256NBR0 K191748 000
M719GSISO095500 K191748 000
M719GSISO095600 K191748 000
M719PM20200 K191748 000
M719PM10210 K191748 000
M719PM10200 K191748 000
M719GSISO115650 K191748 000
M719GSISO115600 K191748 000
M719GSISO115500 K191748 000
M719GSISO115400 K191748 000
M719GSISO095650 K191748 000
M719GSI2520 K191748 000
M719GSI2510 K191748 000
M719GSI2500 K191748 000
M719GSI2300 K191748 000
M719GSI2290 K191748 000
M719GSI2280 K191748 000
M719GSI2210 K191748 000
M719GSI21101XS0 K191748 000
M719GSI21101XL0 K191748 000
M719GSI206040 K191748 000
M719GSI206030 K191748 000
M719GSI2320 K191748 000
M719GSI2350 K191748 000
M719GSI247000 K191748 000
M719GSI239XLS0 K191748 000
M719GSI239STS0 K191748 000
M719GSI239LGS0 K191748 000
M719GSI238T0 K191748 000
M719GSI238D0 K191748 000
M719GSI2370 K191748 000
M719GSI23620 K191748 000
M719GSI20220 K191748 000
M719GSI211030 K191748 000
M719GSI2080 K191748 000
M719GSI31220 K191748 000
M719GSI31210 K191748 000
M719GSI3110 K191748 000
M719GSI2270 K191748 000
M719GSI212LBS0 K191748 000
M719GSI212LBA0 K191748 000
M719GSIAN070700 K191748 000
M719GSI209010 K191748 000
M719GSI209020 K191748 000
M719GSI21102S0 K191748 000
M719GSI21102L0 K191748 000
M719GSI211020 K191748 000
M719GSI21101S0 K191748 000
M719GSI21101L0 K191748 000
M719GSI211010 K191748 000
M719GSI210020 K191748 000
M719GSI210010 K191748 000
M719GSIAN070650 K191748 000
M719GSIAN070600 K191748 000
M719GSIAN070550 K191748 000
M719GSI2311150 K191748 000
M719GSI2310950 K191748 000
M719GSI2310850 K191748 000
M719GSI2310700 K191748 000
M719GSI212XLBS0 K191748 000
M719GSI212XLBA0 K191748 000
M719GSI2330 K191748 000
M719GSI21103XS0 K191748 000
M719GSI2311350 K191748 000
M719GSI234010 K191748 000
M719GSIAN070500 K191748 000
M719GSIAN070450 K191748 000
M719GSIAN070400 K191748 000
M719GSIAN070350 K191748 000
M719GSIAN070300 K191748 000
M719GSI23610 K191748 000
M719GSI234030 K191748 000
M719GSI234020 K191748 000
M719GSI21103XL0 K191748 000
M719GSI20210 K191748 000
M719GSI26403XL0 K191748 000
M719GSI26401L0 K191748 000
M719GSI264010 K191748 000
M719GSI263030 K191748 000
M719GSI263020 K191748 000
M719GSI263010 K191748 000
M179GSIX10611500 K191748 000
M179GSIX10610500 K191748 000
M179GSIX10609500 K191748 000
M719GSI26401S0 K191748 000
M719GSI26401XL0 K191748 000
M719GSI26403S0 K191748 000
M719GSI26403L0 K191748 000
M719GSI264030 K191748 000
M719GSI26402XS0 K191748 000
M719GSI26402S0 K191748 000
M719GSI26402L0 K191748 000
M719GSI264020 K191748 000
M719GSI26401XS0 K191748 000
M179GSIX10608500 K191748 000
M179GSIX10607500 K191748 000
M179GSIX10606500 K191748 000
M719GSI3160950 K191748 000
M719GSISF095700 K191748 000
M719GSISF095650 K191748 000
M719GSISF095600 K191748 000
M719GSISF095550 K191748 000
M719GSISF095500 K191748 000
M719GSISF095450 K191748 000
M719GSISF095400 K191748 000
M719GSI3161150 K191748 000
M719GSI3161350 K191748 000
M179GSIX10605500 K191748 000
M179GSIX10604500 K191748 000
M179GSIX10400 K191748 000
M179GSIX10200 K191748 000
M719GSI3181350 K191748 000
M719GSI3181150 K191748 000
M719GSI3180950 K191748 000
M719GSI3170 K191748 000
M719GSISF095350 K191748 000
M719GSI20200 K191748 000
M719G110020 K191748 000
M719G110010 K191748 000
M719G110000 K191748 000
M719LSIR0010 K191748 000
M719LSI0030 K191748 000
M719GLC4948TI0 K191748 000
M719GLC4947TI0 K191748 000
M719GLC4946TI0 K191748 000
M719G110030 K191748 000
M719G110040 K191748 000
M719GH10200 K191748 000
M719GH0010 K191748 000
M719G110100 K191748 000
M719G110090 K191748 000
M719G110080 K191748 000
M719G110070 K191748 000
M719G110060 K191748 000
M719G110050 K191748 000
M719GLC493TI0 K191748 000
M719GLC491080TI0 K191748 000
M719GLC491060TI0 K191748 000
M719GSI221L150 K191748 000
M719GSI221L130 K191748 000
M719GSI208S0 K191748 000
M719GSI208L0 K191748 000
M719GSI250S0 K191748 000
M719GSI250JM0 K191748 000
M719GSI262020 K191748 000
M719GSI262010 K191748 000
M719GSI221L170 K191748 000
M719GSI221S130 K191748 000
M719GLC491040TI0 K191748 000
M719GLC490S0 K191748 000
M719GLC490L0 K191748 000
M719GLC4882TI0 K191748 000
M719GLC4881TI0 K191748 000
M719GLC467TI0 K191748 000
M719GSI221S170 K191748 000
M719GSI221S150 K191748 000
M719GSI26403XS0 K191748 000
M719GSI21103L0 K191748 000
M719GSISF135350 K191748 000
M719GSISDW135650 K191748 000
M719GSISDW135600 K191748 000
M719GSISDW135550 K191748 000
M719GSISDW135500 K191748 000
M719GSISDW135450 K191748 000
M719GSISDW135400 K191748 000
M719GSISDW135350 K191748 000
M719GSISDW115700 K191748 000
M719GSISDW135700 K191748 000
M719GSISF115350 K191748 000
M719GSISF135300 K191748 000
M719GSISF115700 K191748 000
M719GSISF115650 K191748 000
M719GSISF115600 K191748 000
M719GSISF115550 K191748 000
M719GSISF115500 K191748 000
M719GSISF115450 K191748 000
M719GSISF115400 K191748 000
M719GSISDW115650 K191748 000
M719GSISDW115600 K191748 000
M719GSISDW115550 K191748 000
M719GSISDW095400 K191748 000
M719GSISDW095350 K191748 000
M719GSISD135700 K191748 000
M719GSISD135650 K191748 000
M719GSISD135600 K191748 000
M719GSISD135550 K191748 000
M719GSISD135500 K191748 000
M719GSISD135450 K191748 000
M719GSISDW095450 K191748 000
M719GSISDW095500 K191748 000
M719GSISDW115500 K191748 000
M719GSISDW115450 K191748 000
M719GSISDW115400 K191748 000
M719GSISDW115350 K191748 000
M719GSISDW095700 K191748 000
M719GSISDW095650 K191748 000
M719GSISDW095600 K191748 000
M719GSISDW095550 K191748 000
M719GSISD135400 K191748 000
M719GSIAD070700 K191748 000
M719GSISD095450 K191748 000
M719GSISD095400 K191748 000
M719GSISD095350 K191748 000
M719GSIAW085700 K191748 000
M719GSIAW085650 K191748 000
M719GSIAW085600 K191748 000
M719GSIAW085550 K191748 000
M719GSIAW085500 K191748 000
M719GSISD095500 K191748 000
M719GSISD095550 K191748 000
M719GSIAD070650 K191748 000
M719GSIAD070600 K191748 000
M719GSIAD070550 K191748 000
M719GSIAD070500 K191748 000
M719GSIAD070450 K191748 000
M719GSIAD070400 K191748 000
M719GSIAD070350 K191748 000
M719GSIAD070300 K191748 000
M719GSIAW085450 K191748 000
M719GSIAW085400 K191748 000
M719GSIAW085350 K191748 000
M719GSIAD085700 K191748 000
M719GSIAD085650 K191748 000
M719GSIAD085600 K191748 000
M719GSIAD085550 K191748 000
M719GSIAD085500 K191748 000
M719GSIAD085450 K191748 000
M719GSIAD085400 K191748 000
M719GSIAD085350 K191748 000
M719GSIAW070300 K191748 000
M719GSIAW070350 K191748 000
M719GSIAW085300 K191748 000
M719GSIAW070700 K191748 000
M719GSIAW070650 K191748 000
M719GSIAW070600 K191748 000
M719GSIAW070550 K191748 000
M719GSIAW070500 K191748 000
M719GSIAW070450 K191748 000
M719GSIAW070400 K191748 000
M719GSIAD085300 K191748 000
M719GSISD135350 K191748 000
M719GSISF135700 K191748 000
M719GSI2010 K191748 000
M719GSI2001350 K191748 000
M719GSI2001150 K191748 000
M719GSI2000950 K191748 000
M719GSI2000850 K191748 000
M719GSI2000700 K191748 000
M719GSI308270 K191748 000
M719GSI308220 K191748 000
M719GSI2030 K191748 000
M719GSI2050 K191748 000
M719GSISF135650 K191748 000
M719GSISF135600 K191748 000
M719GSISF135550 K191748 000
M719GSISF135500 K191748 000
M719GSISF135450 K191748 000
M719GSISF135400 K191748 000
M719GSI206020 K191748 000
M719GSI206010 K191748 000
M719GSI3060 K191748 000
M719GSI3050 K191748 000
M719GSI304270 K191748 000
M719GSI2230 K191748 000
M719GSI2220 K191748 000
M719GSI2170 K191748 000
M719GSI2160 K191748 000
M719GSI2150 K191748 000
M719GSI2130 K191748 000
M719GSI212S0 K191748 000
M719GSI212A0 K191748 000
M719GSI2240700 K191748 000
M719GSI2240850 K191748 000
M719GSI304220 K191748 000
M719GSI3030 K191748 000
M719GSI3020 K191748 000
M719GSI3010 K191748 000
M719GSI2250 K191748 000
M719GSI2241350 K191748 000
M719GSI2241150 K191748 000
M719GSI2240950 K191748 000
M719GSI21103S0 K191748 000
M719GSISD115700 K191748 000
M719GSIW1150 K191748 000
M719GSIW0950 K191748 000
M719GSIW0850 K191748 000
M719GSIW0700 K191748 000
M719GSISW135700 K191748 000
M719GSISW135650 K191748 000
M719GSISW135600 K191748 000
M719GSISW135550 K191748 000
M719GSIW1350 K191748 000
M719GSISD095600 K191748 000
M719GSISD115650 K191748 000
M719GSISD115600 K191748 000
M719GSISD115550 K191748 000
M719GSISD115500 K191748 000
M719GSISD115450 K191748 000
M719GSISD115350 K191748 000
M719GSISD095700 K191748 000
M719GSISD095650 K191748 000
M719GSISW135500 K191748 000
M719GSISW135450 K191748 000
M719GSISW135400 K191748 000
M719GSISW115300 K191748 000
M719GSISW095700 K191748 000
M719GSISW095650 K191748 000
M719GSISW095600 K191748 000
M719GSISW095550 K191748 000
M719GSISW095500 K191748 000
M719GSISW095450 K191748 000
M719GSISW095400 K191748 000
M719GSISW115350 K191748 000
M719GSISW115400 K191748 000
M719GSISW135350 K191748 000
M719GSISW135300 K191748 000
M719GSISW115700 K191748 000
M719GSISW115650 K191748 000
M719GSISW115600 K191748 000
M719GSISW115550 K191748 000
M719GSISW115500 K191748 000
M719GSISW115450 K191748 000
M719GSISW095350 K191748 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.