FDA.reportPublic FDA data

iFuse TORQ Implant System

Primary DI
00810055520299
Brand
iFuse TORQ Implant System
Company
Si-Bone Inc.
Model
11545T
Device description
11.5 mm x 45 mm iFuse-TORQ
Published
2021-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K203247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203247000iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021-02-25OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055520299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055520299008100555202998100555202990810055520299

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedA sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically intended to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, 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 implantation instruments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Outer Diameter11.5Millimeter

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
00810055525751Onyx Dual End Set Screw Starter5031022026-10-06
00810055525225Onyx 4.5 mm Navigated Cannulated Tap400539-04502026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated Tap400539-05502026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated Tap400539-06502026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated Tap400539-07502026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip Tap400540-04502026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip Tap400540-05502026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip Tap400540-06502026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip Tap400540-07502026-09-30
00810055525720Onyx Navigated Locking Driver403035-01002026-09-30
00810055525966Onyx Navigated Locking Driver, Cannulated403035-02002026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mm503189-04502026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mm503189-05502026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mm503189-06502026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mm503189-07502026-09-30
00810055526321Onyx iGPS Driver4030572026-09-30
008100555263905.5 mm x 25 mm iFuse Granite Onyx Implant055025BG2026-09-30
008100555264065.5 mm x 30 mm iFuse Granite Onyx Implant055030BG2026-09-30
008100555264135.5 mm x 35 mm iFuse Granite Onyx Implant055035BG2026-09-30
008100555264205.5 mm x 40 mm iFuse Granite Onyx Implant055040BG2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GSIX1270Sacroiliac Joint Fusion SystemGenesys Orthopedics Systems LLCOUR2026-10-19
B387T5II51300SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
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