FDA.reportPublic FDA data

BowTie SI Fusion System

Primary DI
00850053568534
Brand
BowTie SI Fusion System
Company
SAIL FUSION, LLC
Model
90-JFB-000001
Device description
Instrument Reprocessing Tray
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053568534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053568534008500535685348500535685340850053568534

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
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03