FDA.reportPublic FDA data

8.7 mm X 115 mm iFuse TORQ TNT Implant

Primary DI
00810055524310
Brand
8.7 mm X 115 mm iFuse TORQ TNT Implant
Company
Si-Bone Inc.
Model
870115
Device description
8.7 mm X 115 mm iFuse TORQ TNT Implant
Published
2024-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

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
00810055524310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055524310008100555243108100555243100810055524310

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

Contacts#

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

Regulatory Flags#

DUNS number
830127168
Device count
1
Lot or batch
true
Expiration date on label
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
00196449033393A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00196449033409A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22