FDA.reportPublic FDA data

BowTie SI Fusion System

Primary DI
00850053568442
Brand
BowTie SI Fusion System
Company
SAIL FUSION, LLC
Model
90-JFB-300900
Device description
Transfixation Sleeve
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053568442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053568442008500535684428500535684420850053568442

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

Regulatory Flags#

DUNS number
118308843
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
00850053568015BowTie SI Fusion System90-JFA-1000352024-05-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29