FDA.reportPublic FDA data

BowTie SI Fusion System

Primary DI
00850053568015
Brand
BowTie SI Fusion System
Company
SAIL FUSION, LLC
Model
90-JFA-100035
Device description
BowTie Implant, Left, 35mm
Published
2024-05-24
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

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
K232149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232149000BowTie™ SI Joint Fusion SystemSail Fusion, LLC2024-04-20OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053568015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053568015008500535680158500535680150850053568015

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedAn 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 metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118308843
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053568565BowTie SI Fusion System90-JFB-2003002025-01-31
00850053568572BowTie SI Fusion SystemPKG-90-JFA-2000452025-01-31
00850053568558BowTie SI Fusion System90-JFB-1003002025-01-27
00850053568589BowTie SI Fusion SystemPKG-90-JFA-2000502025-01-27
00850053568008BowTie SI Fusion System90-JFA-1000302024-05-24
00850053568022BowTie SI Fusion System90-JFA-1000402024-05-24
00850053568039BowTie SI Fusion System90-JFA-1000452024-05-24
00850053568046BowTie SI Fusion System90-JFA-1000502024-05-24
00850053568053BowTie SI Fusion System90-JFA-1050302024-05-24
00850053568060BowTie SI Fusion System90-JFA-1050352024-05-24
00850053568077BowTie SI Fusion System90-JFA-1050402024-05-24
00850053568084BowTie SI Fusion System90-JFA-1050452024-05-24
00850053568091BowTie SI Fusion System90-JFA-1050502024-05-24
00850053568107BowTie SI Fusion System90-JFA-2000552024-05-24
00850053568114BowTie SI Fusion System90-JFA-2000602024-05-24
00850053568121BowTie SI Fusion System90-JFA-2000652024-05-24
00850053568138BowTie SI Fusion System90-JFA-2000702024-05-24
00850053568145BowTie SI Fusion System90-JFA-2000752024-05-24
00850053568152BowTie SI Fusion System90-JFA-2000802024-05-24
00850053568169BowTie SI Fusion System90-JFA-2000852024-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B387T5II51300SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
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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