SI Joint GSI232

GUDID M719GSI2320

SI Ratcheting T-Handle with Impact Cap

Genesys Orthopedics Systems LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M719GSI2320
• NIH Device Record Key: 3a1577a4-c391-466f-9800-5505c0831358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SI Joint
• Version Model Number: 1
• Catalog Number: GSI232
• 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: true
• 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: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com
• Phone: 512-381-7070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GSI2320 [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

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

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

Devices Manufactured by Genesys Orthopedics Systems LLC

• M719GLL1050 - 3DP Lumbar Interbody: 2024-11-07 Modular Hudson Connect T-Handle
• M179GSIX10200 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Straight Lenke Probe
• M179GSIX10400 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Straight Probe
• M179GSIX10604500 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Awl Tipped Taps 4.5mm
• M179GSIX10605500 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Awl Tipped Taps 5.5mm shaft
• M179GSIX10606500 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Awl Tipped Taps 6.5mm shaft
• M179GSIX10607500 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Awl Tipped Taps 7.5mm shaft
• M179GSIX10608500 - Sacroiliac Joint Fusion System: 2024-09-17 SI-X Nav Awl Tipped Taps 8.5mm shaft