SiJoin T4 Titanium VGSJT42224075

GUDID B387VGSJT422240750

SiJoin T4 Titanium 22x40x7.5

VGI MEDICAL, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: B387VGSJT422240750
• NIH Device Record Key: 602650a0-b465-42bc-a9b9-2dc7e73916aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SiJoin T4 Titanium
• Version Model Number: VG-SJ-T4-2224075
• Catalog Number: VGSJT42224075
• 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
• Phone: 727-565-1235
• Email: cs@vgimedical.com
• Phone: 727-565-1235
• Email: cs@vgimedical.com

Device Dimensions

• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter
• Width: 22 Millimeter
• Length: 40 Millimeter
• Height: 7.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B387VGSJT422240750 [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: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [SiJoin T4 Titanium]

• B387VGSJT4222500: SiJoin T4 Titanium 22x50x5
• B387VGSJT422240750: SiJoin T4 Titanium 22x40x7.5
• B387VGSJT4222400: SiJoin T4 Titanium 22x40x5
• B387VGSJT4222350: SiJoin T4 Titanium 22x35x5
• B387VGSJT4222300: SiJoin T4 Titanium 22x30x5
• B387VGSJT4222250: SiJoin T4 Titanium 22x25x5
• B387VGSJT4222200: SiJoin T4 Titanium 22x20x5
• B387VGSJT4216500: SiJoin T4 Titanium 16x50x5 Implant
• B387VGSJT4216400: SiJoin T4 Titanium 16x40x5 Implant
• B387VGSJT4216350: SiJoin T4 Titanium 16x35x5 Implant
• B387VGSJT4216300: SiJoin T4 Titanium 16x30x5 Implant
• B387VGSJT4216250: SiJoin T4 Titanium 16x25x5 Implant
• B387VGSJT4216200: SiJoin T4 Titanium 16x20x5