FDA.reportPublic FDA data

SiJoin T3 Titanium

Primary DI
B387VGSJT3216300
Brand
SiJoin T3 Titanium
Company
VGI MEDICAL, LLC
Model
VG-SJ-T3-21630
Catalog number
VGSJT321630
Device description
SiJoin T3 Titanium 16x30x5 ImplantThe 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.
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
B387VGSJT3216300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5Millimeter
Length30Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-565-1235cs@vgimedical.com

Regulatory Flags#

DUNS number
019936692
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
B387VGLP18X40X110VerteLP Interbody Fusion DeviceVG-LP-18x40x11VGLP18X40X112016-09-29
B387VGLP18X40X1170VerteLP Interbody Fusion DeviceVG-LP-18X40X11(7)VGLP18X40X1172016-09-28

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