Identity
- Trade Name
- SiJoin T3 Titanium FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- SiJoin T3 Titanium 16x20x5 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. FDA UDI
- Model / Reference
- VG-SJ-T3-21620 FDA UDI
- Description
- SiJoin T3 Titanium 16x20x5 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. FDA UDI
Identifiers
- Catalog Number
- VGSJT321620 FDA UDI
- Primary DI / UDI-DI
- B387VGSJT3216200 FDA UDI
- 510(k) Number
- K213815 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 16 Millimeter FDA UDILength — 20 Millimeter FDA UDIHeight — 5 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
SiJoin T3 Titanium by Vgi Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated.
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- SOLACE Sacroiliac Fixation System — Xenix Medical · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- SacroFuse — SPINEFRONTIER, INC. · Class II
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
- T-FIX™3Dsi Joint Fusion System — CUTTING EDGE SPINE · Class II
- Unity Erodium — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K213815 also covers:
- SiJoin T3 Titanium — VGI MEDICAL, LLC
- SiJoin T3 Titanium — VGI MEDICAL, LLC
- SiJoin T3 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
- SiJoin T4 Titanium — VGI MEDICAL, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vgi Medical, Llc
Sources (1)
- FDA UDI 549fed79-593d-4851-8327-fc58fc371d11 37 fields · synced May 30, 2026