FDA.reportPublic FDA data

iFuse TORQ TNT Navigation Instrument Tray

Primary DI
00810055524716
Brand
iFuse TORQ TNT Navigation Instrument Tray
Company
Si-Bone Inc.
Model
4004601
Device description
iFuse TORQ TNT Navigation Instrument Tray
Published
2024-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241504000iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.2024-08-19OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055524716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055524716008100555247168100555247160810055524716

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-884-3873info@si-bone.com

Regulatory Flags#

DUNS number
830127168
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869397000013XL Instrument Set4000622026-03-24
00869397000020Radiolucent Instrument Set4000912026-03-24
00869397000037Standard Instrument Set4000992026-03-24
00869397000044Removal System Instrument Set4001322026-03-24
008693970000517.5mm & 10.75mm Instrument Set4001452026-03-24
00810055525768iFuse INTRA Ti Implant6030K2026-02-17
00810055525935Granite Point Lock Set Screw5031752025-08-25
00810055525867Driver Sleeve 2 Wrench Assembly4030432025-10-31
00810055525614BL Registration Tube - Broach5030942025-10-20
00810055525621BL Registration Tube - Impactor5030952025-10-20
00810055525638BL Adapter - Dovetail Mount4030022025-10-20
00810055524754iGPS 4.3mm Drill Bit5030422025-09-23
00810055524761iGPS 7.0mm Drill Bit502137-07002025-09-23
00810055524778iGPS 8.5mm Drill Bit502137-08502025-09-23
00810055524785iGPS 10.5mm Drill Bit502137-10502025-09-23
00810055524792Granite iGPS 8.5mm Awl Tip Tap502139-08502025-09-23
00810055524808Granite iGPS 9.0mm Awl Tip Tap502139-09002025-09-23
00810055524815Granite iGPS 9.5mm Awl Tip Tap502139-09502025-09-23
00810055524822Granite iGPS 10.0mm Awl Tip Tap502139-10002025-09-23
00810055524839Granite iGPS 10.5mm Awl Tip Tap502139-10502025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
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07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16