SiJoin T3 Titanium VGSJT321630

GUDID B387VGSJT3216300

SiJoin T3 Titanium 16x30x5 Implant The VGI Medical, LLC SiJoin®T3 Implant consists of a series of titanium alloy (per ASTM F3001) implants that are designed to provide mechanical support by transfixing the sacroiliac joint while biologic fusion occurs. The device consists of the implant body and perpendicular fins to provide stability while fusion occurs. The devices are available in five sizes to accommodate varied patient’s anatomy.

VGI MEDICAL, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: B387VGSJT3216300
• NIH Device Record Key: 1ee78246-fb42-4caf-ada9-a61b3c442374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SiJoin T3 Titanium
• Version Model Number: VG-SJ-T3-21630
• Catalog Number: VGSJT321630
• Company DUNS: 019936692
• Company Name: VGI MEDICAL, 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: true
• 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: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com

Device Dimensions

• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter
• Width: 16 Millimeter
• Length: 30 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B387VGSJT3216300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213815

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [SiJoin T3 Titanium]

• B387VGSJT3222400: SiJoin T3 Titanium 22x40x5
• B387VGSJT3222200: SiJoin T3 Titanium 22x20x5
• B387VGSJT3216300: SiJoin T3 Titanium 16x30x5 Implant The VGI Medical, LLC SiJoin®T3 Implant consists of a series
• B387VGSJT3216200: SiJoin T3 Titanium 16x20x5 Implant The VGI Medical, LLC SiJoin®T3 Implant consists of a series