FDA.reportPublic FDA data

SiJoin T4 Titanium

Primary DI
B387VGSJT4222500
Brand
SiJoin T4 Titanium
Company
VGI MEDICAL, LLC
Model
VG-SJ-T4-22250
Catalog number
VGSJT422250
Device description
SiJoin T4 Titanium 22x50x5
Published
2023-12-12
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
B387VGSJT4222500PrimaryHIBCC0

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
Length50Millimeter
Width22Millimeter

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
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
B387VGLP18X40X110VerteLP Interbody Fusion DeviceVG-LP-18x40x11VGLP18X40X112016-09-29
B387VGLP18X40X1170VerteLP Interbody Fusion DeviceVG-LP-18X40X11(7)VGLP18X40X1172016-09-28

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