FDA.reportPublic FDA data

SiJoin T5 Titanium

Primary DI
B387T5II51300
Brand
SiJoin T5 Titanium
Company
VGI MEDICAL, LLC
Model
T5-II-5130
Catalog number
T5II5130
Device description
SiJoin T5 Inserter
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213815000SiJoin®T3Vgi Medical, Inc.2023-03-29OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B387T5II51300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7275651235orders@vgimedical.com

Regulatory Flags#

DUNS number
019936692
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B387T5II51310SiJoin T5 TitaniumT5-II-5131T5II51312026-10-09
B387VGSJT4216200SiJoin T4 TitaniumVG-SJ-T4-21620VGSJT4216202023-12-12
B387VGSJT4216250SiJoin T4 TitaniumVG-SJ-T4-21625VGSJT4216252023-12-12
B387VGSJT4216300SiJoin T4 TitaniumVG-SJ-T4-21630VGSJT4216302023-12-12
B387VGSJT4216350SiJoin T4 TitaniumVG-SJ-T4-21635VGSJT4216352023-12-12
B387VGSJT4216400SiJoin T4 TitaniumVG-SJ-T4-21640VGSJT4216402023-12-12
B387VGSJT4216500SiJoin T4 TitaniumVG-SJ-T4-21650VGSJT4216502023-12-12
B387VGSJT4222200SiJoin T4 TitaniumVG-SJ-T4-22220VGSJT4222202023-12-12
B387VGSJT4222250SiJoin T4 TitaniumVG-SJ-T4-22225VGSJT4222252023-12-12
B387VGSJT4222300SiJoin T4 TitaniumVG-SJ-T4-22230VGSJT4222302023-12-12
B387VGSJT4222350SiJoin T4 TitaniumVG-SJ-T4-22235VGSJT4222352023-12-12
B387VGSJT4222400SiJoin T4 TitaniumVG-SJ-T4-22240VGSJT4222402023-12-12
B387VGSJT422240750SiJoin T4 TitaniumVG-SJ-T4-2224075VGSJT422240752023-12-12
B387VGSJT4222500SiJoin T4 TitaniumVG-SJ-T4-22250VGSJT4222502023-12-12
B387VGSJT3216200SiJoin T3 TitaniumVG-SJ-T3-21620VGSJT3216202023-06-12
B387VGSJT3216300SiJoin T3 TitaniumVG-SJ-T3-21630VGSJT3216302023-06-12
B387VGSJT3222200SiJoin T3 TitaniumVG-SJ-T3-22220VGSJT3222202023-06-12
B387VGSJT3222400SiJoin T3 TitaniumVG-SJ-T3-22240VGSJT3222402023-06-12
B387VGLP18X40X100VerteLP Interbody Fusion DeviceVG-LP-18x40x10VGLP18X40X102016-09-29
B387VGLP18X40X1070VerteLP Interbody Fusion DeviceVG-LP-18X40X10(7)VGLP18X40X1072016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOUR2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOUR2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOUR2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOUR2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOUR2026-09-25
M719GSIX1210TiLockGenesys Orthopedics Systems LLCOUR2026-08-18
M719G120050SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120060SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120070SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120080SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120090SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120100SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120110SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120120SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120130SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17