SIros-X GSI-XFC095100

GUDID M719GSIXFC0951000

9.5mm x 100mm SIros-X FA Low Top Closed Screw Assembly

Genesys Orthopedics Systems LLC

Spinal bone screw, non-bioabsorbable
Primary Device IDM719GSIXFC0951000
NIH Device Record Keyd6cba933-4879-4aaa-b621-3f9182ea8ea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIros-X
Version Model Number1
Catalog NumberGSI-XFC095100
Company DUNS017921066
Company NameGenesys Orthopedics Systems LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Dimensions

Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter
Length100 Millimeter
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GSIXFC0951000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

[M719GSIXFC0951000]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-26
Device Publish Date2026-01-18

On-Brand Devices [SIros-X]

M719GSIXC105100010.5mm x 100mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105090010.5mm x 90mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105080010.5mm x 80mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105070010.5mm x 70mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105060010.5mm x 60mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105050010.5mm x 50mm SIros-X Low Top Closed Screw Assembly
M719GSIXC105040010.5mm x 40mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09514009.5mm x 140mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09513009.5mm x 130mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09512009.5mm x 120mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09511009.5mm x 110mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09510009.5mm x 100mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09509009.5mm x 90mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09508009.5mm x 80mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09507009.5mm x 70mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09506009.5mm x 60mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09505009.5mm x 50mm SIros-X Low Top Closed Screw Assembly
M719GSIXC09504009.5mm x 40mm SIros-X Low Top Closed Screw Assembly
M719GSIXFL09510009.5mm x 100mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09509009.5mm x 90mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09508009.5mm x 80mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09507009.5mm x 70mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09506009.5mm x 60mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09505009.5mm x 50mm SIros-X FA Low Top Screw Assembly
M719GSIXFL09504009.5mm x 40mm SIros-X FA Low Top Screw Assembly
M719GSIXFC115140011.5mm x 140mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115130011.5mm x 130mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115120011.5mm x 120mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115110011.5mm x 110mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115100011.5mm x 100mm SIros-X FA Low Top Screw Closed Assembly
M719GSIXFC115090011.5mm x 90mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115080011.5mm x 80mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115070011.5mm x 70mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115060011.5mm x 60mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115050011.5mm x 50mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC115040011.5mm x 40mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105140010.5mm x 140mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105130010.5mm x 130mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105120010.5mm x 120mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105110010.5mm x 110mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105100010.5mm x 100mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105090010.5mm x 90mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105080010.5mm x 80mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105070010.5mm x 70mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105060010.5mm x 60mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105050010.5mm x 50mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC105040010.5mm x 40mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC09514009.5mm x 140mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC09513009.5mm x 130mm SIros-X FA Low Top Closed Screw Assembly
M719GSIXFC09512009.5mm x 120mm SIros-X FA Low Top Closed Screw Assembly
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