Sacroiliac Joint Fusion System GSI247-00

GUDID M719GSI247000

SI PL DRILL GUIDE 0

Genesys Orthopedics Systems LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: M719GSI247000
• NIH Device Record Key: 0015c425-2903-4b7f-8c94-8b555c33a58e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sacroiliac Joint Fusion System
• Version Model Number: 1
• Catalog Number: GSI247-00
• Company DUNS: 017921066
• Company Name: Genesys Orthopedics Systems LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GSI247000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191748

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

[M719GSI247000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [Sacroiliac Joint Fusion System]

• M719GSIAD070700: 7.0mm x 70mm SI Anchor - Dual Thread
• M719GSIAD070650: 7.0mm x 65mm SI Anchor - Dual Thread
• M719GSIAD070600: 7.0mm x 60mm SI Anchor - Dual Thread
• M719GSIAD070550: 7.0mm x 55mm SI Anchor - Dual Thread
• M719GSIAD070500: 7.0mm x 50mm SI Anchor - Dual Thread
• M719GSIAD070450: 7.0mm x 45mm SI Anchor - Dual Thread
• M719GSIAD070400: 7.0mm x 40mm SI Anchor - Dual Thread
• M719GSIAD070350: 7.0mm x 35mm SI Anchor - Dual Thread
• M719GSIAD070300: 7.0mm x 30mm SI Anchor - Dual Thread
• M719GSISD095550: 9.5mm x 55mm SI Screw - Dual Thread
• M719GSISD095500: 9.5mm x 50mm SI Screw - Dual Thread
• M719GSISD095450: 9.5mm x 45mm SI Screw - Dual Thread
• M719GSISD095400: 9.5mm x 40mm SI Screw - Dual Thread
• M719GSISD095350: 9.5mm x 35mm SI Screw - Dual Thread
• M719GSIAW085700: 8.5mm x 70mm SI Anchor - Washer Head
• M719GSIAW085650: 8.5mm x 65mm SI Anchor - Washer Head
• M719GSIAW085600: 8.5mm x 60mm SI Anchor - Washer Head
• M719GSIAW085550: 8.5mm x 55mm SI Anchor - Washer Head
• M719GSIAW085500: 8.5mm x 50mm SI Anchor - Washer Head
• M719GSIAW085450: 8.5mm x 45mm SI Anchor - Washer Head
• M719GSIAW085400: 8.5mm x 40mm SI Anchor - Washer Head
• M719GSIAW085350: 8.5mm x 35mm SI Anchor - Washer Head
• M719GSIAW085300: 8.5mm x 30mm SI Anchor - Washer Head
• M719GSIAW070700: 7.0mm x 70mm SI Anchor - Washer Head
• M719GSIAW070650: 7.0mm x 65mm SI Anchor - Washer Head
• M719GSIAW070600: 7.0mm x 60mm SI Anchor - Washer Head
• M719GSIAW070550: 7.0mm x 55mm SI Anchor - Dual Thread
• M719GSIAW070500: 7.0mm x 50mm SI Anchor - Washer Head
• M719GSIAW070450: 7.0mm x 45mm SI Anchor - Washer Head
• M719GSIAW070400: 7.0mm x 40mm SI Anchor - Washer Head
• M719GSIAW070350: 7.0mm x 35mm SI Anchor - Washer Head
• M719GSIAW070300: 7.0mm x 30mm SI Anchor - Washer Head
• M719GSIAD085700: 8.5mm x 70mm SI Anchor - Dual Thread
• M719GSIAD085650: 8.5mm x 65mm SI Anchor - Dual Thread
• M719GSIAD085600: 8.5mm x 60mm SI Anchor - Dual Thread
• M719GSIAD085550: 8.5mm x 55mm SI Anchor - Dual Thread
• M719GSIAD085500: 8.5mm x 50mm SI Anchor - Dual Thread
• M719GSIAD085450: 8.5mm x 45mm SI Anchor - Dual Thread
• M719GSIAD085400: 8.5mm x 40mm SI Anchor - Dual Thread
• M719GSIAD085350: 8.5mm x 35mm SI Anchor - Dual Thread
• M719GSIAD085300: 8.5mm x 30mm SI Anchor - Dual Thread
• M719GSISF135350: 13.5mm x 35mm SI Screw - Full Thread
• M719GSISF135300: 13.5mm x 30mm SI Screw - Full Thread
• M719GSISF115700: 11.5mm x 70mm SI Screw - Full Thread
• M719GSISF115650: 11.5mm x 65mm SI Screw - Full Thread
• M719GSISF115600: 11.5mm x 60mm SI Screw - Full Thread
• M719GSISF115550: 11.5mm x 55mm SI Screw - Full Thread
• M719GSISF115500: 11.5mm x 50mm SI Screw - Full Thread
• M719GSISF115450: 11.5mm x 45mm SI Screw - Full Thread
• M719GSISF115400: 11.5mm x 40mm SI Screw - Full Thread